MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HYBRID GLENOID; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	PT-113950
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Inadequate Osseointegration (2646); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision procedure on the right shoulder was performed approximately nine (9) years after an initial anatomic total shoulder replacement due to chronic anterior subluxation.At the patient¿s three-year and five-year postoperative visits, ligament laxity and voluntary instability had been documented while the patient was using crutches for an unrelated hip condition.The event was found when the patient later experienced a dislocation/subluxation and loosening on an unknown date.During the revision, all components were removed without complication, and an antibiotic spacer was placed.Intraoperative cultures were positive for staphylococcus aureus, and the patient was started on postoperative antibiotics.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Please see the associated reports referenced with applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): 113042 (198030).113954 (060700).Associated product information: 118001 (310720).115736 (463440).Unknown palacos cement (unknown).G2: foreign - the event occurred in the united kingdom.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d6; d9; g1; g3; g6; h1; h2; h3; h6 the reported event is not confirmed as a dislocation; however, instability is confirmed by a physician's review of the x-rays.The returned components were examined.Visual examination identified signs of use, wear, and scratches on the articulating and visible surfaces consistent with in vivo use; measured features were verified against the applicable prints.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported infection has a root cause unrelated to the implanted zimmer biomet device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HYBRID GLENOID
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23660159
• Report Number: 0001825034-2025-03806
• Device Sequence Number: 4770185
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: Lay User/Patient
• Device Expiration Date: 02/24/2026
• Device Catalogue Number: PT-113950
• Device Lot Number: 904840
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2016
• 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: H11; H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 187 LB