MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 6.0; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01227.0001825034 -2021 -01228.
Event or Problem Description
It was reported the distributor investigated circulated items and identified sterile packages damaged.No patients involved.Attempts have been made and additional information on the reported event is unavailable at this time.
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.Evaluation of the returned product confirmed damage to the sterile packaging.Sterility has not been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the products when they left zimmer biomet was conforming to specifications.The root cause of the reported event is likely due to transit damage.Upon investigation, it has been determined that the damage to the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and 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 6.0
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11715920
• Report Number: 0001825034-2021-01229
• Device Sequence Number: 19894630
• Product Code: KWA
• UDI-Device Identifier: 00880304498174
• UDI-Public: (01)00880304498174(17)270531(10)6061898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 51-100060
• Device Lot Number: 6061898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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