MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 13X111MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr.Will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00916, 0001825034 - 2021 - 00918, 0001825034 - 2021 - 00919, 0001825034 - 2021 - 00920.

Event Description

It was reported the distributorship identified sterile packages were damaged.No patient involvement.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the reported event.Evaluation confirmed damage to the sterile packaging blister.Sterility had not been compromised.Dhr was reviewed and no discrepancies were found.The likely condition of the products when they left zimmer biomet was conforming to specifications.The root cause of the reported event is likely due to transit damage.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

No further event information available at the time of this report.

• Brand Name: TPRLC XR MP T1 PPS 13X111MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11594607
• MDR Text Key: 245928146
• Report Number: 0001825034-2021-00917
• Device Sequence Number: 1
• Product Code: LPH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-145130
• Device Lot Number: 6165953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1