MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20; HIP PROSTHESIS

Model Number N/A

Device Problems Corroded (1131); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 02/22/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to pain and elevated cobalt and chromium levels approximately sixteen (16) years post-implantation.During the revision, synovitis and trunnion corrosion were noted.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 ¿ associated products : item #01.00214.160 item name #durom us acet cmpnt 60/54, t lot #2316371.Item #01.00181.540 item name #metasul ldh, head, 54, code t, taper 18/20, lot #2314687.Item #00-7711-012-10, item name #standard offset size 12.5 reduced neck length 12/14 neck taper uncemented femoral stem, lot #60414073.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00436.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The patient underwent an initial right tha because of degenerative arthritis.During this procedure a metal-on-metal system from zb was implanted.The patient underwent a first blood test analysis that revealed the presence of high level of metal ions: chromium 1.6 (normal <1.2 mcg/l) and cobalt 8.9 (normal <1.8 mcg/l).The patient underwent a second blood test analysis that revealed the presence of high level of metal ions: chromium 1.6 (normal <1.2 mcg/l) and cobalt 11.4 (normal <1.8 mcg/l).Because of increasing pain, the patient underwent an mri scan of the right hip to evaluate a possible presence of pseudotumor.Results of the scan excluded the presence of the pseudotumor, but confirmed the presence of a right trochanteric bursitis with mild tendinopathy versus strain within the right gluteus medius, gluteus minimus and tensor fascia.Subsequently, the patient underwent revision surgery.Surgical notes of the procedure report the presence of dark clear hip effusion upon incision and synovitis inflammation in the hip.The stem and the cup were deemed well fixed and with no evidence of wear, therefore they were left implanted in the patient.Head and liner were replaced.With the available information, a definitive root cause cannot be established 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 further event information available at the time of this report.

• Brand Name: METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17469110
• MDR Text Key: 320482998
• Report Number: 0009613350-2023-00437
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024422544
• UDI-Public: (01)00889024422544(17)110315(10)2326742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: 03/15/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00185.146
• Device Lot Number: 2326742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2006
• 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): Hospitalization; Required Intervention
• Patient Sex: Male