MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2015-11-25 for UNKNOWN DEPUY CEMENT UNK-KNEE manufactured by 9610921 Depuy Cmw.
[32176650]
Udi: unavailable. 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) for the attune ps fem lt sz9 cem and the attune fb tib base sz8 cem since release for distribution. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s). 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. Dr-002788 has been undertaken to investigate further. Depuy considers the investigation closed at this time. Should the 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
[32176651]
The patient was revised to address concerns of a loosening and pain. Upon revision the patient's patella was well fixed and had no wear. The tibial and femoral components were revised and replaced. The revision operative note indicated in the pre and post op diagnosis it was a loose/failed left tka but did not specify which components were loose. At this time it is unknown if depuy cement was used. Update rec'd 11/13/2015 - the patient's medical records were received. Medical records were reviewed for mdr reportability. Update rec'd 11/13/2015 - the patient's medical records were received. Medical records were reviewed for mdr reportability. According to the medical records, the patient had depuy cement was implanted on (b)(6) 2014. At this time the depuy cement is being reported and the lot information is being updated for the femoral component and tray. The complaint was updated on: 11/25/2015.
Patient Sequence No: 1, Text Type: D, B5
[32312943]
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
| Report Number | 1818910-2015-35994 |
| MDR Report Key | 5251460 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-11-25 |
| Date of Report | 2015-11-25 |
| Date of Event | 2015-08-07 |
| Date Mfgr Received | 2015-11-25 |
| Date Added to Maude | 2015-11-25 |
| 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 |
| 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 | 9610921 DEPUY CMW |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL, LANCASHIRE FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DEPUY CEMENT |
| Generic Name | KNEE OTHER IMPLANT |
| Product Code | KWH |
| Date Received | 2015-11-25 |
| Catalog Number | UNK-KNEE |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 9610921 DEPUY CMW |
| Manufacturer Address | CORNFORD RD BLACKPOOL, LANCASHIRE FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-25 |