MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH STEM STELCOR 4 L; HIP PROSTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a bilateral total hip arthroplasty and approximately 21 years later, during medical checkups, elevated metal ions (cobalt and chromium) were identified in blood work.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical products: artek cup me 38/52; item#: 91.36.38-52; lot#: 2057482; metasul-femoral head 38 m; item#: 19.38.06; lot#: 2065925.Report source: foreign: germany.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00665, 0009613350 - 2022 - 00666.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.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, b5, g3, g6, h1, h2, h6, h10.No product was returned or pictures provided: product evaluation could not be performed.Review of the manufacturing records identified no deviations or anomalies during manufacturing related to the reported event.Devices used for treatment.Medical records were received and reviewed.The patient is male, at the time of the reported event he is 44 years old.The patient underwent a first bilateral tha because of dysplastic arthrosis at both sides.Both cups have been implanted with a low inclination as well as a low anteversion.With the available data 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.

• Brand Name: STEM STELCOR 4 L
• 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: 16003446
• MDR Text Key: 305684965
• Report Number: 0009613350-2022-00664
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2003
• Device Model Number: N/A
• Device Catalogue Number: 36.00.19-040
• Device Lot Number: B273055
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/1999
• 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): Other
• Patient Sex: Male