MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for CER BIOLOXD MOD HD 36MM +3 NK N/A 12-115122 manufactured by Biomet Uk Ltd..
[186670728]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. Concomitant medical products: medical product: g7 neutral e1 liner 36mm h, catalog #: 010000860, lot #: 6060254, medical product: tprlc 133 t1 pps ho 14x148mm, catalog #: 51-104140, lot #: 6616536, medical product: g7 pps ltd acet shell 62h, catalog #: 010000668, lot #: 6463610. 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
[186670729]
It was reported that a patient underwent an initial left total hip arthroplasty. Subsequently, the patient underwent a closed reduction due to dislocation. The complication was resolved with no further issues reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2020-00195 |
| MDR Report Key | 9897765 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2013-02-27 |
| 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 | CER BIOLOXD MOD HD 36MM +3 NK |
| Generic Name | HIP ARTHROPLASTY |
| Product Code | LZO |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 12-115122 |
| Lot Number | 2986051 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |