MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 8.0; PROSTHETIC, HIP

Model Number N/A

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

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

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported implant was not implanted into patient.Taperloc stem was opened to the field.First sterile pack was intact, but the second sterile pack was ripped.Stem was not implanted into the patient; it was passed off the field and a new one was opened to replace it.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

The following sections were updated/corrected : updated: d9; g3; h2; h3; h6.Evaluation of the returned product/photographs provided confirmed the sterile packaging pouch is damaged.Therefore, the reported event is confirmed.Sterility or breach thereof cannot be determined as the packaging was not returned for review.In addition, white debris consistent with the foam packaging was found on the porous coating.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage and packaging design deficiency.A corrective action was performed previously on this product and it falls under the scope of it , the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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 FP TYPE1 PPS HO 8.0
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11258562
• MDR Text Key: 230726234
• Report Number: 0001825034-2021-00199
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304489721
• UDI-Public: (01)00880304489721
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 51-101080
• Device Lot Number: 6257519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1