MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 12X144MM; 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	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Source: foreign: country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during hip surgery, the femoral stem was opened and the nurse in charge of the instrument found that the inner packaging of the product was not vacuumed.A new implant was opened.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product identified pouch 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.Evaluation of the returned product confirmed there is debris inside the sterile packaging which is consistent with the appearance of porous coating.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 transit damage.For the event reported for black debris in pouch the likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage causing the porous coating to shed from the implant, and a packaging design issue.A corrective action has been previously initiated for the reported event.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 SO 12X144MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14411636
• Report Number: 0001825034-2022-01223
• Device Sequence Number: 12160629
• Product Code: LZO
• UDI-Device Identifier: 00880304491823
• UDI-Public: (01)00880304491823(17)310308(10)6674566
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/13/2022

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: 51-103120
• Device Lot Number: 6974566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/24/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 73 KG