MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR FP TYPE1 PPS 7X134MM 1; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2020

Event Type  malfunction  

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 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 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.

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
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10013280
• MDR Text Key: 189579246
• Report Number: 0001825034-2020-01773
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304516908
• UDI-Public: 00880304516908
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1