MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-13 for SHELL POROUS WITH CLUSTER HOLES 54 MM N/A 00620005422 manufactured by Zimmer Manufacturing B.v..
[179311812]
(b)(4). Concomitant medical products: ref 00771301100 lot 61329199 stem size 11, ref 00620005422 lot 61374971 shell 54mm, ref 00630505036 lot 61369377 longevity liner 36mm 3. 5mm offset, ref 00784800300 lot 61190313 kinectiv neck s, ref 00801803602 lot 61424867 versys head 36mm+0. The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00007, 0001822565 - 2020 - 00047, 0001822565 - 2020 - 00048, 0002648920 - 2020 - 00042, 0002648920 - 2020 - 00043.
Patient Sequence No: 1, Text Type: N, H10
[179311813]
It was reported patient underwent initial right total hip arthroplasty. Subsequently, the patient was revised approximately nine (9) year later due to pain, altr, pseudotumor, and elevated metal ion levels. During the revision, it was found that the acetabular shell was excessively anteverted with impingement of the femoral stem against the liner causing a fracture of the liner. Significant corrosion was noted on the femoral head and neck trunnion. The shell, liner, head, and neck were replaced without complication. No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002648920-2020-00043 |
| MDR Report Key | 9707637 |
| Report Source | CONSUMER |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2009-11-18 |
| Date Added to Maude | 2020-02-13 |
| 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 | 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 MANUFACTURING B.V. |
| Manufacturer Street | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 |
| Manufacturer City | MERCEDITA PR 00715 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00715 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHELL POROUS WITH CLUSTER HOLES 54 MM |
| Generic Name | PROSTHESIS, HIP |
| Product Code | JDL |
| Date Received | 2020-02-13 |
| Model Number | N/A |
| Catalog Number | 00620005422 |
| Lot Number | 61374971 |
| Device Expiration Date | 2019-11-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER MANUFACTURING B.V. |
| Manufacturer Address | TURPEAUX INDUSTRIAL PARK ROUTE #1 KM 123.4 BLDG #1 MERCEDITA PR 00715 US 00715 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-13 |