MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 8X101MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Source: (b)(6).Visual inspection of the returned product found the sterile blister is damaged, likely due to heat damage during the manufacturing process.Complaint sample was evaluated and the reported event was confirmed.Review of the device history records identified no related deviations or anomalies during manufacturing.These products were likely non-conforming when they left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.A corrective action was initiated in order to address 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
It was reported that the sterile packaging was damaged.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.

• Brand Name: TPRLC 133 MP T1 PPS SO 8X101MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10696424
• Report Number: 0001825034-2020-03833
• Device Sequence Number: 16937448
• Product Code: KWA
• UDI-Device Identifier: 00880304515314
• UDI-Public: (01)00880304515314(17)300402(10)6773262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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: 51-108080
• Device Lot Number: 6773262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/19/2020
• 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