MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE PRIMARY FEMORAL 133 T1 PPS HO 18X156MM; PROSTHESIS, HIP

Catalog Number	51-104180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Numbness (2415); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Periprosthetic fracture (4902)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Suggested component code: mechanical (g04) ¿ stem.D10: cat# 650-1058 lot# 3211451 cer bioloxd option hd 40mm.Cat# 650-1065 lot# 3213185 cer option type 1 tpr sleve -3.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 2 weeks later due to periprosthetic fracture.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported a patient had an initial left total hip arthroplasty.Subsequently, developed numbness, increasing pain, swelling and ambulation difficulties.Radiographic imaging displayed femoral stem subsidence with a greater trochanter fracture.Approximately 2 weeks post-implantation, the patient underwent a revision where a hematoma was evacuated and the femoral fracture was identified, including one major fracture fragment.The stem, taper, and head were revised, and the fracture was fixated with a plate and six cables.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: a1; b5; b7; e1; g3; h2; h6.D10: cat# 00620206022 lot# 63315618 shell porous with cluster holes 60 mm cat# 00630506040 lot# 65738940 liner standard 3.5 mm offset 40 mm i.D.For use with 60 mm o.D.Shell.Cat# 00625006540 lot# j7431796 bone screw self-tapping 6.5 mm dia.40 mm length.Cat# 00625006525 lot# j7882572 bone screw self-tapping 6.5 mm dia.25 mm length.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and not submitted to mmi as the findings were documented within the medical records.Submission would not enhance the investigation.A definitive root cause cannot be determined.The complaint is confirmed based on the medical record findings.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
No further information at the time of this report.

• Brand Name: TAPERLOC COMPLETE PRIMARY FEMORAL 133 T1 PPS HO 18X156MM
• Common Device Name: PROSTHESIS, HIP
• 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: 22017434
• Report Number: 0001825034-2025-01396
• Device Sequence Number: 8814701
• Product Code: LZO
• UDI-Device Identifier: 00880304499263
• UDI-Public: (01)00880304499263(17)330919(10)7617577
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K200196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/08/2025

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?: No
• Device Catalogue Number: 51-104180
• Device Lot Number: 7617577
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 06/01/2025; 09/02/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/13/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 100 KG