MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 15X150MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Flaked (1246); Use of Device Problem (1670)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110010246g7 osseoti 4 hole shell56mm f 6mm f 6528632, 010000942 g7 hi-wall e1 liner 40mm f 6569735, 650-1058 cer bioloxd option hd40mm 2960381, 650-1065 cer option type 1 tprsleve -3 2959056.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon implanted the wrong size stem during an initial surgery.The stem was removed and replaced with a smaller stem.During removal, it was noticed that porous coating had shed from the stem.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A tprlc 133 t1 pps ho , was returned and evaluated against the complaint.Visual inspection found black debris consistent with the porous material within the decontamination bag.The coating appears to be slightly damaged on the edge near the neck.No areas were observed where a large amount of coating has become detached from the stem.The neck is scratched.The implant does not have a large amount of pc flaking when rubbed with the thumb.The porous coating approval sheets were reviewed and found to be within specification.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

It was reported that the surgeon was implanting a size 15mm high offset taperloc hip stem and it started to shed some of the porous coating on the lateral side.The surgeon did a washout of the surgical site, but he could not be certain that all of the pieces were removed due to their size.Surgeon decided to use a smaller stem size.No additional information available.

• Brand Name: TPRLC 133 T1 PPS HO 15X150MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9201338
• MDR Text Key: 162817505
• Report Number: 0001825034-2019-04705
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-104150
• Device Lot Number: 6562035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR