MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM MOD HD STD NECK TP1 TAPER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	163662
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: taperloc hip stem.Item: unknown.Lot: unknown.28mm i.D.54mm o.D.Size i bearing.Item: 110031017.Lot: 66299937.G2: foreign ¿ australia.H6: suggested component code: mechanical (g04) ¿ head.The product was requested but was not returned by the hospital and will therefore not be sent 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 underwent a hip revision approximately one month post implantation due to instability and leg length discrepancies.During the procedure, it was noted that a decision was made to remove the resurfacing cup and replace with a g7 dual mobility.The taperloc stem was left in situ and the 28mm t1 taper head and dm bearing removed.Cup was replaced and new 28mm and dm bearing was inserted.Due diligence is complete as multiple attempts were made; however, no further information is available.

• Brand Name: 28MM MOD HD STD NECK TP1 TAPER
• 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 ; 5745260384
• MDR Report Key: 25359645
• Report Number: 0001825034-2026-01530
• Device Sequence Number: 9808452
• Product Code: LPH
• UDI-Device Identifier: 00887868308277
• UDI-Public: (01)00887868308277(17)321212(10)J7399113
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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 Catalogue Number: 163662
• Device Lot Number: J7399113
• 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: 05/05/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown