MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING AR COM XL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was indicated that the product has been received by zimmer biomet and 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: 0001825034-2017-09811, 0001825034-2017-09812.

Event Description

It was reported that the surgeon experienced a problem assembling the humeral bearing with the baseplate during a reverse total shoulder arthroplasty.As a result, the poly experienced damage near the locking mechanism of the baseplate and the locking ring experienced damage as well.Following a 5 minute delay, the surgeon opened new components and experienced no further problems.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).

Manufacturer Narrative

(b)(4).Concomitant medical products: comp rvs tray co 44mm lot#652190 item#115370, comp primary stem 11mm mini lot#546700 item#113631, comp lk scr 3.5hex 4.75x30 st lot# 061500 item#180553 , comp lk scr 3.5hex 4.75x20 st lot#817520 item#180551, comp rvrs shldr glnsp std 36mm lot#343450 item#115310, comp nlk scr 3.5hex 4.75x25 st lot#820720 item#180559, comp rvrs 25mm bsplt ha+adptr lot#996420 item#010000589, comp rvs cntrl 6.5x40mm st/rst lot#991060 item# 115398, comp.Rev shldr 9 in steinmann lot#871200 item# 405800.The reported is confirmed as the visual inspection of the returned products revealed that the locking ring was bent and the poly showed scratches.The marking/identification was also illegible.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Compatibility check noted no issues.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING AR COM XL
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6994254
• MDR Text Key: 91298045
• Report Number: 0001825034-2017-09812
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/19/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115364
• Device Lot Number: 812440
• Other Device ID Number: H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1