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 2019-02-20 for GTS STANDARD FEMORAL STEM SIZE -2 N/A PS129GM2 manufactured by Biomet France S.a.r.l..
[136627126]
(b)(4). Concomitant medical products and therapy dates: exceed cup size 50, head ceramic size 28, exceed polyethylene insert size 28. Report source, foreign - event occurred in (b)(6). Device evaluated by mfr? The device was not evaluated as the batch number was not communicated and the product was not returned. The device was not returned to the manufacturer. Therefore it could not be analyzed. The device manufacturing quality record could not be reviewed as lot number of the product was not communicated. With the available information, the exact root cause of the event could not be determined. Please note that the patient fall was mentioned as related to the implant failure in the event description. 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
[136627127]
It was reported that a patient underwent an initial hip procedure on (b)(6) 2013. Subsequently, the patient was revised due to femoral implant failure after fall on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006946279-2019-00131 |
| MDR Report Key | 8353648 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-02-20 |
| Date of Report | 2019-09-03 |
| Date of Event | 2013-11-02 |
| Date Mfgr Received | 2019-09-02 |
| Date Added to Maude | 2019-02-20 |
| 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 | 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 | GTS STANDARD FEMORAL STEM SIZE -2 |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OCG |
| Date Received | 2019-02-20 |
| Model Number | N/A |
| Catalog Number | PS129GM2 |
| Lot Number | NOT COMMUNICATED |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-20 |