MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Neuropathy (1983); Scar Tissue (2060); Cognitive Changes (2551); Metal Related Pathology (4530)

Event Date 06/29/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure of the left hip approximately thirteen (13) years post implantation due to suspected metallosis.Trunnion of the epoch stem and the inside of the head showed signs of corrosion.The patient had a cobalt level of 19.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02185.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04)- head.Visual examination of the returned product identified scratches on the spherical surface.Taper hole shows dark foreign debris on the taper hole bottom and walls.No other damage was noted.The head was sent for analysis.Results: the taper of the returned device was reviewed and assigned a modified goldberg score of (b)(4).A score of (b)(4) corresponds to damage over the majority (b)(4)) of the surface with severe corrosion attack and abundant corrosion debris.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the description of metallosis is not confirmed radiographically.Potentially, cross-sectional imaging would better depict findings of metallosis.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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

It was reported that patient had bilateral total hips.Patient underwent a left hip arthroplasty and was revised thirteen (13) years post implantation due to suspected metallosis.It was reported that the patient experienced cognitive and neuro related issue due to high metal ion levels, cobalt level of 23.3.There was noticeable scaring noted during the left revision.The head and liner were removed.The liner was destroyed upon removal and the trunnion of the 11 epoch fc and inside of the head showed visible signs of corrosion.The cocr femoral head was replaced with a biolox head and a new liner was implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: a1, b5, g3, g6, h2, h6.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.

Event Description

It was reported that the patient had an initial left total hip arthroplasty.Subsequently the patient was revised thirteen (13) years post implantation due to tribocorrosion, elevated metal ions, and altr.During the revision noted extensive scarring and moderate corrosion.The liner and head were exchanged without complications.The shell and stem remained implanted.

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.Proposed component code: mechanical (g04)- head.Medical record timeline was provided.Review of the provided records identified the following: patient had a initial left total hip arthroplasty.Subsequently revised due to tribocorrosion, elevated metal ions, and altr.During the revision noted extensive scar response of the hip.Moderate corrosion to the head and neck taper was noted.The timeline also notes: ¿despite the corrosion of the neck taper, i elected to leave the femoral component in place, planning to utilize a ceramic head with a titanium taper sleeve to cover the existing neck taper.The existing neck taper was not so badly damaged that i was concerned about the mechanical stability of a new femoral head.¿ neck cleaned and dried.Shell was well fixed and remained intact, liner removed and noted the ¿typical membrane that we see int these tribocorrosion cases¿, this membrane was debrided.Rom: stable throughout, leg lengths equal.No complications were noted.A demand letter was also received stating cobalt levels were 23.3, and then 19.5, ¿persistently elevated¿.Patient complaining of back pain/stiffness, right leg numbness, surgeon decided to revise left hip first.A definitive root cause cannot be determined.Based on the product review and medical record timeline, the complaint is 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.

• Brand Name: FEMORAL HEAD 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: 15084387
• MDR Text Key: 296387738
• Report Number: 0002648920-2022-00167
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/09/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801803201
• Device Lot Number: 61123366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 09/29/2022; 05/02/2024; 05/28/2024; 08/09/2024
• Supplement Dates FDA Received: 10/04/2022; 05/23/2024; 06/20/2024; 08/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2008
• 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: ITEM# 00630505032, ZIMMER LINER LOT# 61094564.; UNKNOWN EPOCH STEM.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 65 KG