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 2018-05-24 for COMPREHENSIVE REVERSE E1 44-36 STANDARD HUMERAL BEARING N/A EP-115393 manufactured by Zimmer Biomet, Inc..
[109163697]
(b)(4). Concomitant medical products: catalog# 113613, comprehensive primary stem 13 mm micro, lot# 421430. Catalog# 115370, comprehensive reverse tray co 44 mm, lot# 676680. Catalog# 115310, comprehensive reverse shoulder glenosphere standard 36 mm, lot# 719350. Catalog# 010000589, comprehensive reverse 25 mm baseplate ha + adapter, lot# 457470. Catalog# 115394, comprehensive reverse central 6. 5 x 20 mm st/rst, lot# 305970. Catalog# 180553, comprehensive locking screw 3. 5hex 4. 75x30 st, lot# 641770. Catalog# 180551, comprehensive locking screw 3. 5hex 4. 75x20 st, lot# 041430. Catalog# 180552, comprehensive locking screw 3. 5hex 4. 75x25 st, lot# 571900. (b)(6). The device will not be returned for analysis; however, an investigation of the reported event is in progress. 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: 0001825034-2018-03540, 0001825034-2018-03543, 0001825034-2018-03545, 0001825034-2018-03548.
Patient Sequence No: 1, Text Type: N, H10
[109163698]
It was reported that a patient underwent an initial reverse total shoulder arthroplasty. Subsequently, the patient was revised due to infection. The patient developed wound complications and culture p. Acne infection. During revision surgeon revised the stem, tray, liner, glenosphere and taper, and completed the surgery by inserting antibiotic spacers.
Patient Sequence No: 1, Text Type: D, B5
[132640749]
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2018-03544 |
| MDR Report Key | 7541192 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-05-29 |
| Device Manufacturer Date | 2017-09-29 |
| Date Added to Maude | 2018-05-24 |
| 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 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPREHENSIVE REVERSE E1 44-36 STANDARD HUMERAL BEARING |
| Generic Name | PROSTHESIS, SHOULDER |
| Product Code | PAO |
| Date Received | 2018-05-24 |
| Model Number | N/A |
| Catalog Number | EP-115393 |
| Lot Number | 376840 |
| ID Number | (01) 00880304 54315 7 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-05-24 |