MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LARGE DIAMETER HD 48/N; HIP PROSTHESIS

Model Number N/A

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 11/06/2021

Event Type  Injury  

Event Description

It was reported from legal that a patient underwent an initial left total hip arthroplasty.Subsequently, the patient presented with pain and difficulty ambulating.Labs revealed elevated cobalt and chromium levels.The patient was revised; during which metallosis was found upon removal of the head and adapter.The stem was well fixed and left intact.All other components were revised without complications.The patient¿s metal ion levels have since receded, but the muscle damage and difficulty from the metallosis remains.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10 - medical devices: durom acet comp 4/48 code n; item# (b)(4); lot# 2452308.Head adapter m/0 12/14-18/20; item# (b)(4); lot# 2455297.Alloclassic variall slv stem 6; item# (b)(4); lot# 2438250.G2 - foreign: italy.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00271.0009613350 - 2023 - 00604.0009613350 - 2023 - 00605.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4): 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.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories identified additional similar complaints for the reported items and the part and lot combinations.Complaints are monitored in order to identify potential adverse trends.Medical records and legal documentation were provided and reviewed by a health care professional.The patient is male, born in 1942 and underwent an initial left tha on oct 10, 2008 due to coxarthrosis.Subsequently, the patient suffered of pain in the left hip causing difficulty walking with marked inability to bear weight; therefore, the patient underwent the following exams: - (b)(6) 2018 blood cobalt 10.47 (normal <1.0), serum chromium 3.41 (normal <0.5) and urine cobalt 20.4 (normal <2.5), urine chromium 7.5 (normal <2.0).- (b)(6) 2018 x-ray without signs of loosening.- (b)(6) 2019 x-rays with no significant findings in the left hip.- (b)(6) 2019 blood cobalt 7.04 (normal <1.0), serum chromium 2.51 (normal <0.5).- (b)(6) 2019 chromium 2.61 (normal <0.5), cobalt 12.78 (normal <1.0).- (b)(6) 2021 chromium 2.68 (normal <1.0), cobalt 23.19 (normal <1.0).Due to the high level of metal ions and pain, the patient underwent a revision surgery on (b)(4) 2021.Surgical notes of this procedure reports presence of liquid effusion in the join.The stem was found stable and well integrated, therefore left in place.The head and the head adapter showed signs of metallosis with the presence of "tar-like material", therefore they were removed together with the shell.With the available information, a definitive root cause cannot be determined.

Event Description

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

• Brand Name: METASUL LARGE DIAMETER HD 48/N
• 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: 17994356
• MDR Text Key: 326356745
• Report Number: 0009613350-2023-00604
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024422520
• UDI-Public: (01)00889024422520(17)130430(10)2448184
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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: 04/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00181.480
• Device Lot Number: 2448184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2008
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male