MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 11.0 T1 PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported that patient underwent a left hip revision approximately 3 months post implantation due to pain and difficulty walking. During the procedure, the femoral component was noted to have subsided. The cup and liner remained implanted while the femoral components were removed and replaced. Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4). Concomitant medical products: 110010246 ¿ g7 shell ¿ 64809428; 30103606 ¿ g7 liner ¿ 65051580; 650-0662 ¿ biolox head ¿ 3033498. (b)(4). Medical records were provided and reviewed by a health care professional. Review of the available records identified the following. Fwb with antalgic gait, rom: 0-90 degrees. Having severe pain and problems walking. Revision of femoral component only due to stem subsidence. Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event. 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.

• Brand Name: TPRLC 133 MP TYPE1 PPS SO 11.0 T1
• Type of Device: PROSTHESIS, 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: 14734021
• Report Number: 0001825034-2022-01431
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304514294
• UDI-Public: (01)00880304514294(17)310401(10)6992251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 51-106110
• Device Lot Number: 6992251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sex: Male
• Patient Weight: 134 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Patient Outcome(s): Hospitalization; Required Intervention