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

Catalog Number	51-106090
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned devices found debris inside the sterile packaging which is consistent with the appearance of porous coating and white debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging.The sterile pouches have lost their vacuum seal.The inside of the pouches are scuffed.Biological debris from surgery was found on the pouches, which is not considered a failure.The sterility, or breach thereof, cannot be determined as the blister was not returned for evaluation.Concomitant medical product: item # 51-106090/ tprlc 133 mp type1 pps / lot 6751788.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded the root cause of the reported event can be attributed to transit damage.The sterile packaging configuration is moving to a double blister configuration.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02344.
Event or Problem Description
It was reported that during an initial hip procedure the surgeon discovered the taperloc stem to contain debris within the sterile packaging.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TPRLC 133 MP TYPE1 PPS
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12315266
• Report Number: 0001825034-2021-02345
• Device Sequence Number: 4490408
• Product Code: KWZ
• UDI-Device Identifier: 00880304514614
• UDI-Public: (01)00880304514614(17)290422(10)6531264
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K110400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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 Catalogue Number: 51-106090
• Device Lot Number: 6531264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1