MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 18X156MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 10/27/2020

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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04119.

Event Description

It was reported that during total hip arthroplasty the surgical tech began opening the packaging for the stem, there was black residue at both ends of the stem and the packaging had a small opening at the distal end of the stem.Total delay of the surgery was an estimated 20-25 minutes.No patient involvement.No additional information.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed by evaluation of the returned product/photographs.Device history record (dhr) was reviewed and no discrepancies related to the event were found.The root cause of the reported event it likely to be damage during transit.Evaluation of the returned product/photographs provided confirmed the following: lot #3873636 : damage to sterile pouch and debris inside the sterile packaging which is consistent with the appearance of the porous coating.Lot #3873652 damage to sterile blister and debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging and the porous coating inside the sterile barrier.Further evaluation found the outer carton to be damaged.The products were returned opened.The sterility of the devices cannot be determined.The likely condition of the device when it left zimmer biomet is conforming to specification.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TPRLC 133 T1 PPS SO 18X156MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10854071
• MDR Text Key: 216690251
• Report Number: 0001825034-2020-04120
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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: 51-103180
• Device Lot Number: 3873652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1