MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-13 for TM REVISION ACETABULAR SHELL N/A 00700006020 manufactured by Zimmer, Inc..
[45191002]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[45191003]
It was reported that the patient underwent hip arthroplasty revision due to infection.
Patient Sequence No: 1, Text Type: D, B5
[47318656]
Information has been received and the device that has contributed to the reported event is manufactured by another manufacturing site. Zimmer biomet (b)(4) will file an mdr for this information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2016-01576 |
| MDR Report Key | 5655243 |
| Date Received | 2016-05-13 |
| Date of Report | 2016-04-15 |
| Date of Event | 2014-04-08 |
| Date Mfgr Received | 2016-05-16 |
| Date Added to Maude | 2016-05-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CARRIE SCHNEIDER |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TM REVISION ACETABULAR SHELL |
| Product Code | KWB |
| Date Received | 2016-05-13 |
| Model Number | N/A |
| Catalog Number | 00700006020 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-05-13 |