MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR FP TYPE1 PPS 7X134MM 1; 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	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01770, 0001825034-2020-01771, 0001825034-2020-01772.Reported event was confirmed by review of photographs.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to transit damage.Customer has indicated that the product will be returned to the manufacturer for evaluation, however, the product has yet to be received.Alternately, evaluation of the photographs provided confirmed that the sterile packaging (blister) is damaged.The likely condition of the parts when they left zimmer biomet control is considered conforming based on the device history record (dhr) review.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 during investigation of circulated items, devices were identified with damage to their sterile packages.No patients were involved.No additional information available.
Event or Problem Description
Not reportable: upon investigation, it has been determined that the damage to the packaging did not breach the sterility.Event is no longer considered reportable for this device, and initial report should be voided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by visual examination of the device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was traced to transport/storage issues.Products have been returned.Visual evaluation of the returned products identified that the outer sterile cavities have been damaged.Sterility has not been compromised.Not reportable: upon investigation, it has been determined that the damage to the pacakaging did not breach the sterility.Event is no longer considered reportable for this device, and initial report should be voided.

• Brand Name: TPRLC XR FP TYPE1 PPS 7X134MM 1
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10013280
• Report Number: 0001825034-2020-01773
• Device Sequence Number: 19622855
• Product Code: LPH
• UDI-Device Identifier: 00880304516908
• UDI-Public: 00880304516908
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• 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,Followup
• Report Date (Section B): 06/09/2020

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 Expiration Date: 02/26/2026
• Device Model Number: N/A
• Device Catalogue Number: 51-102070
• Device Lot Number: 3735251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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