MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-05-25 for PINN CAN BONE SCREW 6.5MMX20MM 121720500 manufactured by Johnson & Johnson Medical (suzhou) Ltd. 3006356043.
[45956244]
Additional narrative: (b)(4). This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[45956245]
(b)(4). Patient in the year 2003 was subjected to a right hip arthroplasty in which received an asr implant. Due to mobilisation of the implant, the patient was subjected to a revision surgery ((b)(6) 2013) in which was implanted a pe/ceramic implant. Following this revision the patient accused pain and difficult in dehambulating. Subsequent examination detected a mobilisation of the implants and metallosis with cr level ions of 04 microg. /l update rec'd 27 april 2016 - the patient's medical records were received. Medical records were reviewed for mdr reportability. According to the medical records, the patient has a loose acetabular component. At this time, the patients cup and screws are being reported for loosening.
Patient Sequence No: 1, Text Type: D, B5
[47357613]
Examination of the reported devices was not possible as they were not returned. The investigation can draw no conclusion with the information provided. Based on the inability to determine root cause, the need for corrective action has not been indicated. Depuy still considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[75526864]
Depuy still considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[75526865]
Update 20-apr-2017: medical records received. After review of the medical records for mdr reportability, the medical records indicated a wound infection in (b)(6) 2014. Cup loosening was also mentioned in (b)(6) 2014. The patient was revised on (b)(6) 2015 for infection. All implants were removed and spacers were placed. Revision operative note wasn't provided so it? S unknown if loosening and metallosis was found at revision. No labs were provided for the alleged high metal ion levels (labs were provided after the revision). Part/lot is being updated for the stem and the stem is now being reported.
Patient Sequence No: 1, Text Type: D, B5
[109798364]
Patient Sequence No: 1, Text Type: N, H10
[117258596]
Depuy16-12. Patient in the year 2003 was subjected to a right hip arthroplasty in which received an asr implant. Due to mobilisation of the implant, the patient was subjected to a revision surgery ((b)(4) 2013) in which was implanted a pe/ceramic implant. Following this revision the patient accused pain and difficult in deambulating. Subsequent examination detected a mobilisation of the implants and metallosis with cr level ions of 04 microg. /l update rec'd (b)(4) 2016 - the patient's medical records were received. Medical records were reviewed for mdr reportability. According to the medical records, the patient has a loose acetabular component. At this time, the patients cup and screws are being reported for loosening. The complaint was updated on: (b)(4) 2016. Update (b)(4) 2017: medical records received. After review of the medical records for mdr reportability, the medical records indicated a wound infection in (b)(4) and (b)(4) of 2014. Cup loosening was also mentioned in (b)(4) of 2014. The patient was revised on (b)(4) 2015 for infection. All implants were removed and spacers were placed. Revision operative note wasn't provided so it? S unknown if loosening and metallosis was found at revision. No labs were provided for the alleged high metal ion levels (labs were provided after the revision). Part/lot is being updated for the stem and the stem is now being reported. This complaint was updated on: (b)(4) 2017. Update (b)(4) 2017: additional information received. Updated date of implant. This complaint was updated on (b)(4) 2017. Update (b)(4) 2017: additional information received. Updated date of implant. This complaint was updated on (b)(4) 2017. The reported event has been evaluated and will be monitored. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2016-20006 |
| MDR Report Key | 5680014 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-05-25 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-03-29 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2013-01-28 |
| Date Added to Maude | 2016-05-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 |
| Manufacturer Street | NO.299 CHANGYANG ST SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU 21512-6 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 21512-6 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX20MM |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | NDJ |
| Date Received | 2016-05-25 |
| Catalog Number | 121720500 |
| Lot Number | D12090053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 |
| Manufacturer Address | NO.299 CHANGYANG ST SUZHOU INDUSTRIAL PARK SUZHOU 21512-6 CH 21512-6 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-25 |