MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TLOC 133 OFFSET INSERTER ASSY; INSTRUMENT, HIP

Catalog Number	51-222224
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the inserter is damaged and the tip was no longer with the instrument.There was no patient involvement.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Report source: netherlands.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Visual examination of the returned product identified the inserter to be fractured at the tip.The tip was not returned.A wear ring is present around the tip at the fracture site.The strike plate has been dinged.The shaft is also dinged near the grip.Additionally, the device was sent for further analysis.Analysis determined the instrument fracture show river lines and indication of a slight hinge suggesting a bending overload mode of failure.Complaint confirmed based on evaluation of returned product.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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 additional event information to report at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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: TLOC 133 OFFSET INSERTER ASSY
• Common Device Name: INSTRUMENT, 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: 17252650
• Report Number: 0001825034-2023-01466
• Device Sequence Number: 6840343
• Product Code: LPH
• UDI-Device Identifier: 00880304509719
• UDI-Public: (01)00880304509719(11)211201(10)B75521
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2023

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: 51-222224
• Device Lot Number: B75521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 08/30/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/01/2023; 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown