MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X40MM ST/RST; PROSTHESIS, EXTREMITIES

Catalog Number	115398
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device product code - phx.Concomitant medical devices: part# 180555; lot# 018400; part# 180555; lot# 018410; part# 180556; lot# 232620; part# 180555; lot# 283200; part# 115310; lot# 141420; part# 113613; lot# 923000; part# 110031399; lot# 64682740 part# 110031418; lot# 64578844; part# 110027734; lot# 600120; part# 110031378; lot# 600150.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the first available pre-revision post op record identified the following: limited examination secondary to suboptimal positioning.Also, there is grid artifact which further limits evaluation.The articular region of the arthroplasty is not well characterized and overall, the glenosphere is limited in evaluation.Grossly normal alignment.Hardware appears grossly intact.No obvious periprosthetic lucency or hardware fracture.The glenosphere screws appear intact.Bones appear intact without fracture.Subcutaneous/soft tissue emphysema noted in the axillary region and in the soft tissues surrounding the humerus.Review of the second available pre-revision post op record identified the following: disassociation of the glenosphere with the outer component displaced to the level of the proximal humerus diaphysis.The humerus is therefore not in alignment with the glenoid component and is located superior and lateral to the glenoid.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to use error as the central screw was not fully seated.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.
Event or Problem Description
It was reported by the pmi group the patient underwent a shoulder procedure approximately five (5) months ago.Subsequently, the patient underwent a revision approximately three (3) weeks post-implantation due to glenosphere disassociation caused by the surgeon not fixating the central screw completely down.A new central screw was put in and poly was exchanged.Attempts have been made and no further information has been provided.

• Brand Name: COMP RVS CNTRL 6.5X40MM ST/RST
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10778936
• Report Number: 0001825034-2020-03996
• Device Sequence Number: 19101177
• Product Code: PHX
• UDI-Device Identifier: 00880304677104
• UDI-Public: (01)00880304677104
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 115398
• Device Lot Number: 317390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention