MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 20X160MM; PROSTHESIS, HIP

Catalog Number	51-103200
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the revision, the stem would not disengage from the head.The stem and head were removed and new ones were used to complete the procedure.There was no harm or health impact to the patient.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: cat #: 650-0660 / delta ceramic fem hd 36/-3mm / lot #: 3159543.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that during a revision surgery for dislocation, the stem also had to be revised because it could not disengage from the head.The stem and head were both removed and new ones were used to complete the procedure.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d4; g3; h2; h3; h4; h6.Corrected: b5; h1; d6; h6 health impact and clinical codes.H6: proposed component code: mechanical: stem.Performed a visual inspection of the items returned.Unable to verify item and lot information for the stem as it is located on the neck taper of the stem and is covered by the ceramic head.Both the stem and the head show signs of use.The stem has gouges and scratches around the neck just below the ceramic head and also has some debris located in the porous coating.Unable to separate the ceramic head from the stem so they remain seized together.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.This complaint was confirmed based on the returned devices unable to be separated.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: TPRLC 133 T1 PPS SO 20X160MM
• 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: 18921896
• Report Number: 0001825034-2024-00685
• Device Sequence Number: 20730209
• Product Code: LZO
• UDI-Device Identifier: 00880304498365
• UDI-Public: (01)00880304498365(17)320517(10)7244589
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K200196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 51-103200
• Device Lot Number: 7244589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Male