MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 12.0; PROSTHESIS, HIP

Catalog Number	51-106120
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inserting the stem, the doctor noted that it looked like the grit blast was coming off the stem.There were no consequences or impact to the patient.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat#: 31-323220/ 3.2mmx20mm rnglc+ acet drl bit/lot#: 546040.Cat#: 110010244/ g7 osseoti 3 hole shell 52mm e/ lot#: 65459659.Cat#: 30103605/ g7 vit e neutral lnr 36mm e/lot #: 65560835.Cat#: 00-6250-065-20/ bone screw 6.5x20 selftap/ lot#: j7238089.Cat#: 00-6250-065-20/ bone screw 6.5x20 selftap/ lot#: j7348330.Cat#: 51-106120/ tprlc 133 mp type1 pps so 12.0/lot#: 7041275.Cat#: 650-0661/ delta ceramic fem hd 36/0mm/lot#: 3119037.Cat#: 98-0001-000-37/ pr prm st/oss lh cp/ve ln/cer/ins.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 component code: mechanical (g04) ¿ stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.The device history records were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: the auto blaster was down so they had to use a manual blaster, however, the device inspection showed the device was conforming per spec.Therefore, it is unlikely that the deviation contributed to the reported event.A definitive root cause cannot 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 further event information available at the time of this report.

• Brand Name: TPRLC 133 MP TYPE1 PPS SO 12.0
• 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: 15958800
• Report Number: 0001825034-2022-02771
• Device Sequence Number: 5526318
• Product Code: KWA
• UDI-Device Identifier: 00880304514317
• UDI-Public: (01)00880304514317(17)310611(10)7041275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 51-106120
• Device Lot Number: 7041275
• 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: 11/20/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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
• 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: Male