MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE PRIMARY FEMORAL 133 FP TYPE1 PPS HO 6.0; PROSTHESIS, HIP

Catalog Number	51-101060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); Swelling/ Edema (4577)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-0660 lot# 3211566 delta ceramic fem hd 36/-3mm; cat# 110010243 lot# 66971253 g7 osseoti 3 hole shell 50mm d; cat# 30103604 lot# 66603929 36mm i.D.Size d neutral liner.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 left total hip arthroplasty.Subsequently the patient fell 24-36 hours postoperatively.At the 2-week postop visit x-ray revealed a periprosthetic fracture of the femur.The patient was revised approximately two weeks post implantation due to periprosthetic fracture, pain, and swelling.During the revision noted a hematoma that was evacuated.The stem and head were exchanged without complications.The fracture was repaired with cerclage cables.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.H6: component code: mechanical (g04) - stem.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.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: approximately two months ago: pain and swelling after fall.Fracture at femur with cup loosening.Subsidence of stem and periprosthetic fracture.Hematoma/seroma.A definitive root cause cannot be determined.It is unknown if the patient's fall caused or contributed to the reported event.Additionally, it is unknown if surgical technique was followed.It is also unknown if this caused or contributed to the reported event.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 event information is available at the time of this report.

• Brand Name: TAPERLOC COMPLETE PRIMARY FEMORAL 133 FP TYPE1 PPS HO 6.0
• 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: 21508835
• Report Number: 0001825034-2025-00539
• Device Sequence Number: 19981138
• Product Code: KWA
• UDI-Device Identifier: 00880304499072
• UDI-Public: (01)00880304499072(17)301201(10)6908381
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K103755
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 51-101060
• Device Lot Number: 6908381
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 95 KG