MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2015-08-31 for CEMENTRALIZER 11.0 137620000 manufactured by Depuy Orthopaedics Inc Us.
[24617370]
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. Udi:(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24617371]
The patient was revised because of infection. Update 8/4/15-pfs and medical records received. After review of the medical records for mdr reportability, the revision operative note indicated infection, instability, pain, and discomfort. Litigation now alleges infection so the head and liner are now being reported and all other implants are being reported as infection was confirmed per medical records. It should be noted that only the head and liner were revised during the (b)(6) 2014 operation. The stem has already been reported on (b)(4). The complaint was updated on:8/31/2015
Patient Sequence No: 1, Text Type: D, B5
[27463521]
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
[41758574]
Depuy still considers this investigation closed at this time.
Patient Sequence No: 1, Text Type: N, H10
[41758575]
Update (b)(6) 2016, (b)(6) 2016, (b)(6) 2016, (b)(6) 2016 medical records received. Medical records reviewed for mdr reportability. There is no new additional information that would affect the existing investigation. The complaint was updated on: (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[44616476]
Additional narrative: 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 | 1818910-2015-29350 |
| MDR Report Key | 5042652 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2015-08-31 |
| Date of Report | 2015-08-04 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2016-05-02 |
| Device Manufacturer Date | 2004-09-07 |
| Date Added to Maude | 2015-08-31 |
| 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 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTRALIZER 11.0 |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | LTO |
| Date Received | 2015-08-31 |
| Catalog Number | 137620000 |
| Lot Number | Y3PB51000 |
| Device Expiration Date | 2009-09-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-31 |