MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 8X101MM; PROSTHESIS, HIP

Catalog Number 51-108080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00042.0001825034-2024-00043.D10: cat #: 010000662 / g7 pps ltd acet shell 50d/ lot #: 3389888.Cat #: 010000856 / g7 neutral e1 liner 36mm d / lot #: 3364238.Cat #: 6501057 / cer bioloxd option hd 36mm / lot #: 965570.Cat #: 6501065 / cer option type 1 tpr sleve -3 / lot #: 339980.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that a patient, with a history of dysplasia, was diagnosed with minimal greater trochanter bursitis approximately four years post implantation.Now, approximately nine years post implantation, the patient is experiencing intermittent pain, severe pain with walking and aggravated pain with lifting leg in a straight position, while lifting the knee, lying and twisting.Pain subsides while sitting and has been diagnosed with psoas tendinitis.The patient is being treated conservatively for the time being and no further notes of an increase in pain have been reported.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: x-ray review found overall sizing is appropriate.No radiolucency.Normal bone quality.No signs of loosening, impingement, wear, radiolucency.No factors identified to contribute to ongoing pain.Medical records identified pain severe with walking.Right hip pain around ilipsoas area ongoing since surgery.Chronic back pain and psoas tendinitis.Complaint is confirmed based on the provided medical records.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.

Event Description

No additional event information to report at this time.

• Brand Name: TPRLC 133 MP T1 PPS SO 8X101MM
• 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: 18450811
• MDR Text Key: 332174926
• Report Number: 0001825034-2024-00044
• Device Sequence Number: 1
• Product Code: KWA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 51-108080
• Device Lot Number: 3391462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Race: White