MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2016-07-15 for PINN CAN BONE SCREW 6.5MMX30MM 121730500 manufactured by 3006356043 Johnson & Johnson Medical.
[49634436]
(b)(4). 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
[49634437]
Patient has been revised to address a wound infection. The patient's medical records were received. Medical records were reviewed for mdr reportability. According to the medical records, the patient was experiencing pain and erythema. The patient underwent a debridement of the right hip wound on (b)(6) 2016. During the procedure the surgeon noted that he could not identify any communication of the infection with the joint. Intraoperative wound cultures were consistent with staph aureus and contamination of the underlying prosthetic joint components could not be ruled out. The patient underwent a second i&d with explantation of the right total hip arthroplasty on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[50364264]
No device associated with this report was received for examination. A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy 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
| Report Number | 1818910-2016-23232 |
| MDR Report Key | 5797869 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-07-15 |
| Date of Report | 2016-06-20 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-07-21 |
| Device Manufacturer Date | 2016-01-26 |
| Date Added to Maude | 2016-07-15 |
| 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 |
| 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 | J3006356043 JOHNSON & JOHNSON MEDICAL |
| 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 6.5MMX30MM |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | NDJ |
| Date Received | 2016-07-15 |
| Catalog Number | 121730500 |
| Lot Number | D15082659 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3006356043 JOHNSON & JOHNSON MEDICAL |
| 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 | 2016-07-15 |