MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STANDARD 36MM DIAMETER BEARING; PROSTHESIS, SHOULDER

Catalog Number	110031418
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Joint Laxity (4526); Muscle/Tendon Damage (4532); Joint effusion (4849)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to disassociation of the poly from the humeral tray.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat: 110031405 lot: 66868112 mini standard thickness +6 mm taper offset 40 mm diameter humeral tray cat: 115310 lot: j820583 comp rvrs shldr glnsp std 36 mm.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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 that the patient had a primary left reverse tsa.The patient was presented with dysfunction left shoulder and pain, and was revised three months post initial procedure due to disassociation of the poly from the humeral baseplate.Surgeon noted upon entry found scar tissue, bloody effusion and partially torn subscapularis tendon.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a3, a4, b4, b5, b7, d2, d6a, g3, g6, h1, h2, h6, h11.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h10.The reported event is confirmed from provided op notes.Visual examination of the provided picture identified the humeral tray and bearing have been explanted, along with the taper adaptor and glenosphere.The inside mating surface of the humeral tray and the bottom of the humeral bearing show signs of use with marked surfaces and discoloration.Additional evaluation cannot be completed without product return.Part and lot information verified from product etch.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient experienced severe pain and shoulder dysfunction and was revised due to poly disassociation from the humeral tray which led to instability; poly liner was found superior to proximal humerus in subacromial space.Scar tissue was encountered and there was large bloody effusion in the joint space; no visual evidence of infection.The subscapularis tendon repair was partially torn.The humeral tray and glenosphere had notable scratches from metal-on-metal contact; tissue debrided.A definitive root cause cannot be determined.If any further information is found that 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
No further event information is available at the time of this report.

• Brand Name: STANDARD 36MM DIAMETER BEARING
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21375006
• Report Number: 0001822565-2025-00358
• Device Sequence Number: 14409582
• Product Code: KWS
• UDI-Device Identifier: 00887868231490
• UDI-Public: (01)00887868231490(17)290529(10)66714909
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2025

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
• Device Catalogue Number: 110031418
• Device Lot Number: 66714909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 02/23/2025; 06/17/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/26/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 91 KG