MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 13X146MM MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Information (3190)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: country: (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 - 2020 - 03638, 0001825034 - 2020 - 03640.

Event Description

It was reported by the distributorship that the products were found to be nonconforming.Our incoming inspection team member found debris in the sterile package.No additional information.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d10; g4; h2; h3; h4; h6.Complaint sample was returned and evaluated against the reported event.Evaluation of the returned product/photographs provided confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.The reported event is confirmed.Dhr was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet was non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.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.

• Brand Name: TPRLC XR T1 PPS 13X146MM MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10600098
• MDR Text Key: 208969895
• Report Number: 0001825034-2020-03639
• 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: 12/01/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-105130
• Device Lot Number: 6830442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1