MAUDE Adverse Event Report: Zimmer Biomet, Inc. G7 OSSEOTI 3 HOLE SHELL 48MM C; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	110010242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, following a right total hip arthroplasty, radiographs demonstrated heterotopic ossification of the right acetabulum, and the patient reported moderate pain and stiffness managed with daily nsaids and cbd.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: cat# 650-1055 lot# 2957937 cer bioloxd option hd 28mm cat# 110024461 lot# 343080 g7 dual mobility liner 38mm c cat# ep-200144 lot# 791810 act artic e1 hip brg 28x38mm cat# 5110006033 lot# 3947646 tprlc 133 fp type1 pps so 6.0 the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 48MM C
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• 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 ; +1(574)526-0384
• MDR Report Key: 50751866
• Report Number: 0001825034-2026-02740
• Device Sequence Number: 10309314
• Product Code: LPH
• UDI-Device Identifier: 00880304544178
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110010242
• Device Lot Number: 6464745
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 180 LB
• Patient Race: Black Or African American