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

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 07/25/2019

Event Type  Injury  

Event Description

It was reported the patient underwent a right hip arthroplasty.Nine years post implantation the patient was revised for unknown reasons.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: 00620005622 shell porous with cluster holes 56 mm o.D.61491765.00630505632 liner standard 32 mm i.D.For use with 56 mm o.D.Shell 61486551.00625006530 bone screw self-tapping 6.5 mm dia.30 mm length 60861074.00625006525 bone screw self-tapping 6.5 mm dia.25 mm length 61547351.00771100920 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 extended offset 61523467.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 record identified no deviations or anomalies during manufacturing.An adequate complaint history review cannot be performed as the complication, failure mode, and/or harm experienced by the user is unknown.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04)- head.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 and a revision occurred nine years post implantation due to pain and elevated metal ions.During the revision, altr was identified within the joint, as well as discoloration on the trunnion and femoral head.Hypertrophic bone was identified around the acetabulum, and surface wear on the liner.The liner and head were explanted and exchanged with no complications noted.Root cause unchanged.This complaint was confirmed based on the provided medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated report: 0001822565 - 2023 - 01635, 0002648920 - 2023 - 00124.

Event Description

It was reported by legal a patient underwent a right hip arthroplasty.Subsequently, patient was revised with head and liner exchange nine years post implantation due to pain, elevated metal ion levels, metal related pathology, corrosion, and wear.Ossification was also noted during the procedure.No further complications have been reported.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROTHESIS, 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: 16861941
• MDR Text Key: 314479171
• Report Number: 0002648920-2023-00087
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2023

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: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00801803201
• Device Lot Number: 61542828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 05/23/2023; 07/25/2023
• Supplement Dates FDA Received: 06/16/2023; 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2010
• 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