MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 8.0; 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	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.(b)(6).
Event or Problem Description
It was reported upon inspection in the (b)(6) warehouse that the team member found debris in the sterile package.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay updated/corrected information.Product was returned and evaluated.A visual evaluation of the returned product identified a stain located on the outside of the sterile blister; the outer carton had already been opened when returned.The complaint was confirmed by visual evaluation.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is no longer considered reportable as there are no serious injury or harm to the patient reported for this event or prior events with same or similar products; the initial report should be voided.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 FP TYPE1 PPS SO 8.0
• 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: 12347826
• Report Number: 0001825034-2021-02460
• Device Sequence Number: 19916760
• Product Code: LZO
• UDI-Device Identifier: 00880304489660
• UDI-Public: (01)00880304489660(17)310510(10)7017668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 51-100080
• Device Lot Number: 7017668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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