MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 18.0 M T1; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign country: (b)(6).The device will not be returned for analysis, as the device remains 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 the package wasn¿t vacuumed seal but we didn¿t have another implant to use so we implanted it anyway.No additional information.
Event or Problem Description
No further event 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: b4, b5, g3, h2, h3, h6 reported event was confirmed due to the review of photos.Visual evaluation of photo provided of the pouch found damage including but not limited to, scuff marks, creasing, and loss of vacuum seal.No evidence of sterile packaging breaches were found that would explain the loss of the vacuum seal.The reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.For the event reported for damaged pouch the likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage, and a packaging design issue.For the event reported for vacuum seal issues the likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to a packaging design issue.A corrective action has been initiated to address the issue.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 MP TYPE1 PPS HO 18.0 M T1
• 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: 14497292
• Report Number: 0001825034-2022-01285
• Device Sequence Number: 20381418
• Product Code: KWA
• UDI-Device Identifier: 00880304513594
• UDI-Public: (01)00880304513594(17)310826(10)7091763
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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 Model Number: N/A
• Device Catalogue Number: 51-107180
• Device Lot Number: 7091763
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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: Unknown