MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-09-04 for 32MM MOD HEAD COCR +12MM NECK N/A 163673 manufactured by Biomet Uk Ltd..
[119040602]
(b)(4). Report source, foreign - event occurred in (b)(6). (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[119040603]
It has been reported by the patient's legal representative that the patient underwent an initial left hip arthroplasty and subsequently the patient experienced an infection and a wound washout procedure was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2018-01047 |
| MDR Report Key | 7841784 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-09-04 |
| Date of Report | 2018-11-28 |
| Date of Event | 2014-10-02 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 2010-12-07 |
| Date Added to Maude | 2018-09-04 |
| 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 UK LTD. |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3XA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 32MM MOD HEAD COCR +12MM NECK |
| Generic Name | HIP PROSTHESIS |
| Product Code | JDB |
| Date Received | 2018-09-04 |
| Model Number | N/A |
| Catalog Number | 163673 |
| Lot Number | 0000587055 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-09-04 |