MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM INSERTER 12/14 TAPER INSTRUMENTATION; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unknown cpt stem unknown.G2: foreign: canada.Visual examination of the returned product identified wear on the handle and body from previous uses in the form of nicks and scratches.Threaded tip has deformation damage to the leading threads.No other damage was noted.The stem was not returned for review.Function testing of the inserter could not be performed due to the damage on the leading threads.Review of the device history records identified no deviations or anomalies during manufacturing for the stem inserter.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed, it is unknown if the threads were damaged prior to or during use to affect the assembly.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the stem inserter does not engage onto the stem.A new stem was used to complete the case and the broken inserter was used to complete the procedure.

• Brand Name: STEM INSERTER 12/14 TAPER INSTRUMENTATION
• Common Device Name: HIPS, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19092004
• Report Number: 0001822565-2024-01224
• Device Sequence Number: 20757858
• Product Code: LXH
• UDI-Device Identifier: 00889024146013
• UDI-Public: (01)00889024146013(10)63676135
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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 Model Number: N/A
• Device Catalogue Number: 00833401300
• Device Lot Number: 63676135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown