MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE; PROSTHESIS, HIP

Catalog Number	51-104160
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unk size 16 broach h6: suggested component code: mechanical (g04) - stem the product has been received by zimmer biomet and 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 stem sat 5mm proud compared to the final broach.The stem was not used.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1-3; b5; d10; g3; h2.D10: cat: 51-203150 lot: 252036 tprlc 133 rasp/prov 15x150mm 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 stem sat 5mm proud compared to the final broach.The stem was not used.Had to implant a stem one size under the broach and wasted the initial stem.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.Visual examination of the returned product identified the stem has scratches on the neck, trunnion (taper), and flat surface of the proximal end.The distal end is blasted and has multiple shiny spots where it appears the blast may have been rubbed off.No other damage was noted during visual evaluation.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided.Review identified the following: the femoral component was inserted to the appropriate depth and rotation without any evidence of calcar cracks.The initial 16 mm lateralized stem chosen stood up extremely proud over the resected calcar level about least 5-6mm.Read rasping was undertaken several times with a 15 and 16 mm rasp and despite that the 60 mm stem would not advance to the appropriate level.A 15 mm lateralized taper lock complete stem was chosen it was placed with the appropriate position and it was proud by only 2 mm.The 16 mm stem was not utilized for the above reason.Two undated xrs of a left tha not submitted for further review.Post surgical images would not capture the event.The root cause of the reported issue is attributed to off-label combinations.As per ifu, 'the surgeon is to be thoroughly familiar with the implants, instruments, and surgical technique prior to performing surgery." as per surgical technique, "when preparing for the taperloc complete microplasty® stem placement, be sure to use the appropriate broach." the high offset stem and reduced distal broach are off- label combinations and would have caused the reported issue.Complaint is confirmed.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.

• Brand Name: TAPERLOC COMPLETE
• 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: 22827060
• Report Number: 0001825034-2025-02484
• Device Sequence Number: 4553087
• Product Code: LZO
• UDI-Device Identifier: 00880304491854
• UDI-Public: (01)00880304491854(17)350427(10)J7943048
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K200196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 51-104160
• Device Lot Number: J7943048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 01/15/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/10/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2025
• 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
• Patient Sex: Male