MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-01-22 for ARPE HEAD CURVE LONG +2 N/A P0203AL4 manufactured by Biomet France S.a.r.l..
[133709013]
(b)(4). Report source, foreign - event occurred in (b)(6). The device was not returned to the manufacturer. Therefore it could not be analyzed the device manufacturing quality record indicates that the released product met all requirements to perform as intended. No root cause could be determined, however this is an expected risk that the implant can be damaged in case of fall of the patient if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[133709014]
It was reported that patient underwent revision surgery due to dislocation after a fall. The implant head was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00059 |
| MDR Report Key | 8266227 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-22 |
| Date of Report | 2019-01-21 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2017-10-31 |
| Date Added to Maude | 2019-01-22 |
| 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. H BATAILLE |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal | 26903 |
| Manufacturer Phone | 0334757591 |
| Manufacturer G1 | BIOMET FRANCE S.A.R.L. |
| Manufacturer Street | PLATEAU DE LAUTAGNE BP75 |
| Manufacturer City | VALENCE CEDEX 26903 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 26903 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARPE HEAD CURVE LONG +2 |
| Generic Name | METACARPAL PROSTHESIS |
| Product Code | KWG |
| Date Received | 2019-01-22 |
| Model Number | N/A |
| Catalog Number | P0203AL4 |
| Lot Number | 0001267935 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET FRANCE S.A.R.L. |
| Manufacturer Address | PLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-01-22 |