MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 18X156MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that there was loose metal debris in the sterile package.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product/provided photos identified damage to sterile blister and pouch with debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging and the porous coating.Sterility has been compromised.The outer carton has been torn likely from opening the product complaint sample was evaluated and the reported event was confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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.As part of a project, the sterile packaging configuration is moving to a double blister configuration.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 18X156MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11862098
• Report Number: 0001825034-2021-01561
• Device Sequence Number: 1100272
• Product Code: JDI
• UDI-Device Identifier: 00880304498358
• UDI-Public: (01)00880304498358(17)290306(10)6498109
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• 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: 51-103180
• Device Lot Number: 6498109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/21/2021
• 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