MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGEN/RNGLC+ LTD 52MM SZ 23; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00973, 0001825034-2023-00975, 0001825034-2023-00976.D10: cat#103531, lot# 008980, ti low profile screw 6.5x20mm.Cat# 103534, lot# 452840, ti low profile screw 6.5x35mm.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 patient had a left total hip arthroplasty that was subsequently revised approximately 11 years later.It was noted an increase in clicking and development of pain.Radiographic imaging showed the femoral head popped off the trunnion even though the femoral head remained in the acetabulum and articulating with the cup.During the revision, the femoral component was found severely damaged, deformed, and corroded.Osteolysis found in the region of the calcar, an extended osteotomy was performed for removal of the well-fixed femoral component, the acetabular liner was broken from the trunnion hitting into it, and the locking ring was deformed.Luque wires were implanted to support the extended osteotomy.The cup remained without damage and was left in place.The locking ring and liner were revised and all other implants were replaced with competitor product.Attempts have been made and no further information has been provided.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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: femoral head popped off the trunnion of femoral component.Black metallosis in joint.Trunnion of the femoral component was severely damaged and deformed and very corroded.Osteolysis in region of calcar.Acetabular liner was broken from the trunnion hitting into it.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: REGEN/RNGLC+ LTD 52MM SZ 23
• 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: 16875693
• MDR Text Key: 314628534
• Report Number: 0001825034-2023-00974
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: PT-116052
• Device Lot Number: 633970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• 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 Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 139 KG