MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 9X137MM; PROSTHETIC, HIP

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	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign; netherlands.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that the broach of the stem in question had a good press fit to the osteotomy plane of the collum.The definitive stem in question was jammed to at least 2 cm below the coating and then removed.Afterwards, they used the same size broach again and carefully inserted a little deeper to a few mm below osteotomy just after extensive spongiosa excision and lateralization to cortical bone.Stem inserted and again jammed to 2cm below coating.Stem just did not go deeper without risk of femoral fracture (dull sound during impact).Other taperloc stem same size inserted effortlessly.Intervention took no longer than 30 minutes as a result and no impact on patient.The doctor felt that possibly the coating of the particular stem is thicker than usual and therefore simply did not fit properly in the femur.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h6: component code: mechanical (g04) - stem.Visual examination of the returned product identified there is debris on the porous coating.Height and width were checked and found within conformance to the print.Unable to confirm complaint as the product dimensions are within specification.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.No device problem was found.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
There is no update to the prior event description provided.

• Brand Name: TPRLC 133 T1 PPS HO 9X137MM
• Common Device Name: PROSTHETIC, 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: 17286190
• Report Number: 0001825034-2023-01510
• Device Sequence Number: 17695733
• Product Code: LZO
• UDI-Device Identifier: 00880304499249
• UDI-Public: (01)00880304499249(17)320421(10)7240434
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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 Model Number: N/A
• Device Catalogue Number: 51-104090
• Device Lot Number: 7240434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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: 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: Prefer Not To Disclose