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 2015-10-27 for UNKNOWN DEPUY SZ. 28X54 NEUTRAL LINER UNK-HIP manufactured by Depuy Orthopaedics, Inc..
[29311481]
Additional narrative: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. 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 at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. See section for any product information received. Depuy synthes has been informed that the catalog number and lot number is not available.
Patient Sequence No: 1, Text Type: N, H10
[29311482]
Patient was revised due to pain and poly wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2015-33731 |
| MDR Report Key | 5179948 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-20 |
| Date of Event | 2015-10-20 |
| Date Mfgr Received | 2015-10-20 |
| Date Added to Maude | 2015-10-27 |
| 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 | STEVE DOWELL |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743714918 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| 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 | UNKNOWN DEPUY SZ. 28X54 NEUTRAL LINER |
| Generic Name | HIP ACETABULAR INSERT/LINER |
| Product Code | KWB |
| Date Received | 2015-10-27 |
| Catalog Number | UNK-HIP |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-27 |