MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE PRIMARY FEMORAL 133 FP TYPE1 PPS HO 8.0; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00620205222 lot# 65712808 shell porous with cluster holes 52 mm.Cat# 00625006530 lot# j7405189 bone screw self-tapping 6.5 mm dia.30 mm length.Cat# 00625006525 lot# 65601589 bone screw self-tapping 6.5 mm dia.25 mm length.Cat# 00630505036 lot# 65672783 liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells.Cat# 650-0660 lot# 3140405 delta ceramic fem hd 36/-3mm.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 1 year later due to leg length discrepancy.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.Proposed component code: mechanical: stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Findings: severe femoral head and acetabular arthritis.Left length gain was noted to be 10mm per our preoperative plan.Excellent stability was noted in abduction, external rotation, extension as well as in flexion, adduction, and internal rotation.A definitive root cause cannot be determined.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 FP TYPE1 PPS HO 8.0
• 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: 20053819
• Report Number: 0001825034-2024-02064
• Device Sequence Number: 7971157
• Product Code: LZO
• UDI-Device Identifier: 00880304489721
• UDI-Public: (01)00880304489721(17)320406(10)7220633
• 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: 2023
• Device Explanted Year: 2024
• 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): 01/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-101080
• Device Lot Number: 7220633
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: Male
• Patient Weight: 72 KG