MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 17.0; PROSTHETIC, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Unequal Limb Length (4534)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 650-1057 cer bioloxd option hd 36mm lot number 2904520, 650-1066 cer opt type 1 tpr sleve 0mm lot number 2920994, 010000860 g7 neutral e1 liner 36mm h lot number 6109006, 110017108 g7 finned 4 hole shell 62h lot number 3972309.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Event Description

It was reported pt underwent a revision procedure 9 months post-implantation due to an undersized stem with minor subsidence.The femoral head and acetabular liner were replaced.No additional complications have been reported.There is no additional information available at the time of this report.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.H6: component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on review of medical records.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: short leg deformity right hip, trendelenburg lurch.Component subsidence of right femur, bone ingrowth.Stable well fixed femoral component.Well positioned and well-fixed acetabular component.Right leg measured 14mm of leg length discrepancy with the left.Taper was undamaged and showed no signs of corrosion.No pain.A definitive root cause cannot be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 component code: mechanical (g04) - stem.Review of complaint history found no additional related issues for this/these item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: healed well, no pain 5 years post operation.The additional information does not change the outcome of the previous investigation.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

There is no update to the prior event description provided.

• Brand Name: TPRLC 133 FP TYPE1 PPS HO 17.0
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16691684
• MDR Text Key: 312803382
• Report Number: 0001825034-2023-00762
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304499157
• UDI-Public: (01)00880304499157(17)251028(10)3661564
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-101170
• Device Lot Number: 3661564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 07/03/2023; 04/05/2024
• Supplement Dates FDA Received: 07/07/2023; 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White