MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TLOC 133 MP SP T1 PPSHO 6X97.5 1; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: 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 - 02570, 0001825034 - 2020 - 02571, 0001825034 - 2020 - 02572, 0001825034 - 2020 - 02573, 0001825034 - 2020 - 02574, 0001825034 - 2020 - 02576.

Event Description

It was reported circulated items were investigated and identified debris in sterile packages.No patients were involved.No additional information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, d10, g4, h2, h3, h4, h6.Evaluation of the returned product/photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.The reported event is confirmed.Device history record (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.This complaint is being reviewed through the capa process.Upon receipt of additional information, it has been determined that this device did not contain any debris that would compromise sterility.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not contain any debris that would compromise sterility.The initial report was forwarded in error and should be voided.

• Brand Name: TLOC 133 MP SP T1 PPSHO 6X97.5 1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10239086
• MDR Text Key: 198315361
• Report Number: 0001825034-2020-02575
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K110400
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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: 51-109060
• Device Lot Number: 3590302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1