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 2018-10-30 for BIO-MOD HUM STEM 12MM 113708 manufactured by Biomet Uk Ltd..
[125534918]
(b)(4). Concomitant medical product - not sdr hm hd 48x20 o/st without pin, item: 106516, lot: 589855. Therapy date - remains implanted. Report source, foreign - event occurred in the (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: 3002806535-2018-01166.
Patient Sequence No: 1, Text Type: N, H10
[125534919]
It was reported that a patient underwent an initial left shoulder arthroplasty. Subsequently, a revision procedure is being planned due to patient's native glenoid cavity wear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2018-01167 |
| MDR Report Key | 8020956 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-30 |
| Date of Report | 2019-02-07 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2003-04-03 |
| Date Added to Maude | 2018-10-30 |
| 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 | BIO-MOD HUM STEM 12MM |
| Generic Name | UNKNOWN |
| Product Code | MJT |
| Date Received | 2018-10-30 |
| Catalog Number | 113708 |
| Lot Number | 625045 |
| Device Expiration Date | 2013-03-31 |
| 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 | 2018-10-30 |