MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 14X148MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 10/13/2020

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 14 standard offset taperloc complete step was opened for usage and the inner sterilized packaging was compromised and the physician would not use it.It looked like bits of porous coating came off and inner plastic coating was scraped in numerous areas.Implant was not implanted.There was no impact to patient or delay in procedure.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.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.Sterility has not been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.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 SO 14X148MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10777696
• MDR Text Key: 214337972
• Report Number: 0001825034-2020-03973
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304491816
• UDI-Public: (01)00880304491816
• 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: 12/22/2020

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: 51-103140
• Device Lot Number: 6636170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1