MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 20X160MM 0MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the distal stem was opened for implantation during a surgical procedure.The inner plastic packaging was perforated and had black marks on the interior of it.The surgeon refused to use this item and wanted a different implant (same size).Surgery was stopped for 45 minutes while we waited for another implant to be delivered.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4, g3, h2, h3, h4, h6.Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product/photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of the porous coating inside the sterile barrier.The sterile pouch was torn.Packaging was returned opened, therefore, the sterility of the device cannot be determined.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event can be attributed to transit damage and packaging design deficiency.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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 133 T1 PPS HO 20X160MM 0MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10927034
• MDR Text Key: 218919322
• Report Number: 0001825034-2020-04237
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• 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: 51-104200
• Device Lot Number: 6450955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1