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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item number 20103605 item name g7 longevity neutral 36mme lot # 65055382, item number 110010244 item name g7 osseoti 3 hole shell52mm e lot # 65048702, item number 650-0661 item name delta ceramic fem hd36/0mm lot # 3063464, item number 51-107100 item name tprlc 133 mp type1 pps ho10.0 lot # 6720772.Review of the device history records identified no deviations or anomalies during manufacturing.Visual inspection of the provided picture identified the tip of the inserter had fractured.Medical records were not provided.A definitive root cause could not 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.Initially incorrectly reported under mfr 0001822565-2021-02528.
Event or Problem Description
It was reported as the surgeon went to use the the femoral impactor he noticed it was cracked.As he touched the tip of the impactor, it fell off.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TLOC 133 OFFSET INSERTER ASSY
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12917719
• Report Number: 0001825034-2021-03262
• Device Sequence Number: 14770071
• Product Code: LPH
• UDI-Device Identifier: 00880304509719
• UDI-Public: (01)00880304509719(10)073392
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 51-222224
• Device Lot Number: 073392
• 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: 11/30/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Female