MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-08-30 for EXCEED ABT 3HL SHELL 44/56MM 124456 manufactured by Biomet Uk Ltd..
[118724203]
(b)(4). Concomitant medical products - olympia stem size 4 left, item 650-0614, lot 3612932, therapy date - (b)(6) 2018; 36mm 12/14 tpr fem hd std , item 650-0888, lot 3907330, therapy date - (b)(6) 2018. Report source, foreign - event occurred in (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01041 and 3002806535-2018-01042.
Patient Sequence No: 1, Text Type: N, H10
[118724204]
It was reported by the njr that a patient underwent an initial left hip arthroplasty and subsequently, a revision procedure was performed due to dislocation and subluxation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2018-01040 |
| MDR Report Key | 7832111 |
| Report Source | FOREIGN |
| Date Received | 2018-08-30 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2019-01-07 |
| Device Manufacturer Date | 2016-07-25 |
| Date Added to Maude | 2018-08-30 |
| 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 | EXCEED ABT 3HL SHELL 44/56MM |
| Product Code | JDD |
| Date Received | 2018-08-30 |
| Catalog Number | 124456 |
| Lot Number | 3842951 |
| 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 | 2018-08-30 |