MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for METASUL LDH HEAD, 46, CODE L, TAPER 18/20 N/A 01.00181.460 manufactured by Zimmer Gmbh.
[138806556]
Concomitant medical products and therapy dates: details of products: item number 0100634054, item name zimmer mmc¢, cup, uncemented, 54 mm/46 mm, code l, lot #2528528. Item number 0100185145, item name metasul ldh, head adapter, s, -4, taper 12/14-18/20, lot # 2476709. Item number 0100551307, item name fitmore, hip stem, uncemented, offset b (extended)/7, taper 12/14, lot # 2513547. The manufacturer did not receive x-rays but received other source documents for review. The device history records were reviewed and found to be conforming. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available, an updated report will be submitted. Zimmer biomet? S reference number of this file is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138806557]
It was reported that patient underwent revision surgery due to elevated metal ions and mild metallosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2019-00137 |
| MDR Report Key | 8421039 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-08-28 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-08-28 |
| Device Manufacturer Date | 2009-11-18 |
| Date Added to Maude | 2019-03-14 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | REACTN/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METASUL LDH HEAD, 46, CODE L, TAPER 18/20 |
| Generic Name | N/A |
| Product Code | KWB |
| Date Received | 2019-03-14 |
| Model Number | N/A |
| Catalog Number | 01.00181.460 |
| Lot Number | 2533911 |
| Device Expiration Date | 2014-10-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-03-14 |