MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM E; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

Catalog Number	010000857
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had been experiencing left hip pain for two months.An x-ray was taken for evaluation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: g7 bonemaster ltd acet shl 52e, item: 010000703, lot: unknown.Sirius hip stem 38-c, item: 51-199335, lot: unknown.Sirius winged centralizer, item: 51-199300, lot: unknown.Delta ceramic fem hd 36/+3mm, item: 650-0662, lot: unknown.G2: foreign ¿ united kingdom.The customer indicated that the product location is unknown at this time; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient had been experiencing left hip pain for two months.An x-ray was taken for evaluation.The patient was diagnosed with osteoarthritis and received regional spinal (intrathecal) anesthesia.It was confirmed that the pain has been resolved, and the event was noted as mild and easily tolerated by the patient, causing minimal discomfort.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2; a3; a4; b5; b7; d4; d10; g3; h2; h6.A2: patient birth year: 1958.D10: g7 bonemaster ltd acet shl 52e.Item: 010000703.Lot: 3382959.Sirius hip stem 38-c.Item: 51-199335.Lot: 202510.Sirius winged centralizer.Item: 51-199300.Lot: unknown.Delta ceramic fem hd 36/+3mm.Item: 650-0662.Lot: 2015091568.The customer indicated that the product remains implanted; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

• Brand Name: G7 NEUTRAL E1 LINER 36MM E
• Common Device Name: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
• 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: 24557280
• Report Number: 0001825034-2026-00536
• Device Sequence Number: 9495558
• Product Code: PBI
• UDI-Device Identifier: 00880304526426
• UDI-Public: (01)00880304526426(17)191002(10)3439199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2026

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 Expiration Date: 10/02/2019
• Device Catalogue Number: 010000857
• Device Lot Number: 3439199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 07/28/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/10/2026; 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11; SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 207 LB