MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for BIOLOX DELTA HEAD 12/14 36X0 N/A 00-8775-036-02 manufactured by Biomet Uk Ltd..
[187570526]
(b)(4). Report source: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Concomitant medical products: medical product: biolox delta cer lnr 36mm e, catalog #: 110003634, lot #: 6548686, medical product: g7 pps ltd acet shell 52e, catalog #: 010000663, lot #: 6629812, medical product: ml taper sz12. 5 std offset, catalog #: 00-7711-012-00, lot #: 64145181. (b)(6). 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
[187570527]
It was reported that a patient underwent an initial right total hip arthroplasty. Subsequently, the patient reported pain and the feeling of the hip locking. An x- ray identified that the ceramic parts are fractured and loose. Revision surgery is planned for (b)(6) 2020. This complaint reports the implant fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2020-00191 |
| MDR Report Key | 9897272 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-05-15 |
| Date Added to Maude | 2020-03-30 |
| 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 | BIOLOX DELTA HEAD 12/14 36X0 |
| Generic Name | HIP ARTHROPLASTY |
| Product Code | LZO |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 00-8775-036-02 |
| Lot Number | 2989510 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-30 |