MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 14X148MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (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 - 02281, 0001825034 - 2020 - 02282, 0001825034 - 2020 - 02283, 0001825034 - 2020 - 02284, 0001825034 - 2020 - 02287.

Event Description

It was reported that during an investigation of circulated items, several devices were identified as having debris in their sterile package.No patients were involved.No additional information is available.

Event Description

Upon receipt of additional information, it has been determined that the product is conforming to specifications.Event is no longer considered reportable, and the initial report was forwarded in error and should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: b4, b5, d4, d10, g4, h2, h3, h4, h6, h10.Complaint sample was evaluated and the reported event was confirmed.Debris inside the sterile packaging is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier.Dhr was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed.D4: udi:(b)(4).Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.

• Brand Name: TPRLC XR T1 PPS 14X148MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10134423
• MDR Text Key: 194673296
• Report Number: 0001825034-2020-02285
• 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: 09/04/2020

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: 51-105140
• Device Lot Number: 3786675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1