MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Inflammation (1932); Necrosis (1971); Pain (1994); Metal Related Pathology (4530)

Event Date 09/13/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial right total hip arthroplasty.Subsequently, the patient was revised approximately 13 years later due to pain, elevated cobalt chrome levels, and mri evidence of trunnionosis.During the revision, necrotic tissue was debrided with trunnionosis noted at the head/neck junction.The stem and shell were well-fixed and left in place.A new locking ring, poly liner, ceramic head, and neck were placed without complications.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 01833, 0001822565 - 2023 - 01834.D10: cat# 00625006525 lot# 61288013 bone scr 6.5x25 self-tap.Cat# 00771301200 lot# 61265772 modular femoral stem press-fit plasma sprayed cementless size 12.5.Cat# 00620005622 lot# 61237887 shell porous with cluster holes 56 mm o.D.Proposed component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.A revision occurred due to pain and elevated metal ions.During the revision, trunnionosis and alval was identified, with poly wear as well.A definitive root cause cannot be determined.This report was previously report under 0001822565 - 2023 - 01831.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: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17929696
• MDR Text Key: 325571059
• Report Number: 0002648920-2023-00247
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2023

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 Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 61287037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male