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

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as the device was implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the stem was not vacuum sealed.Stem was implanted.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 T1 PPS HO 20X160MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12421330
• Report Number: 0001825034-2021-02581
• Device Sequence Number: 3528023
• Product Code: KWL
• UDI-Device Identifier: 00880304499270
• UDI-Public: (01)00880304499270(17)310201(10)6950989
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K200196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 51-104200
• Device Lot Number: 6950989
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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