MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 7.0 T1; PROSTHETIC, 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	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Mfr site: (b)(4).The event reports that the sterile packaging was damaged.This was identified at a zb distribution centre, therefore there was no patient, user, or stakeholder harm.There was no patient involvement.Evaluation of the returned product/photographs provided confirms foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed and blister is damaged.The reported event is confirmed, sterility has been breached.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is non-conforming to specification due to the foreign debris.The root cause of the foreign debris is the operator not following the work instructions provided.The root cause of the damaged blister can be attributed to transit damage and packaging design deficiency.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
It was reported the representative investigated circulated items and identified sterile package damage.No further event information available at the time of this report.

• Brand Name: TPRLC 133 FP TYPE1 PPS HO 7.0 T1
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11472284
• Report Number: 0001825034-2021-00646
• Device Sequence Number: 3471449
• Product Code: KWA
• UDI-Device Identifier: 00880304489769
• UDI-Public: (01)00880304489769(17)280806(10)6348907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101086
• 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
• Report Date (Section B): 03/04/2021

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: 51-101070
• Device Lot Number: 6348907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1