MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48¸ 42, CODE H; HIP PROTHESIS

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problems Inflammation (1932); Pain (1994); Metal Related Pathology (4530)

Event Date 03/14/2017

Event Type  Injury  

Event Description

It was reported by legal that the patient underwent an initial right total hip arthroplasty.Subsequently, the patient presented with intense and chronic pain.Due to metallosis, pseudotumor, elevated metal ions and alval.Revision of the cup and femoral implants was performed approximately 11 years after the initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - unknown mayo femoral implant, item# unknown, lot# unknown; g2 ¿ foreign ¿ france.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 and corrected information.D10 - mayo 12/14 medium item#00-8026-012-00 lot#60253364, metasul large diameter hd 42/h item#01.00181.420 lot#2253628, head adapter l/+4 12/14-18/20 item#01.00185.147 lot#2263626.No evaluation of the pictures/x-rays as the reported event is already known and addressed.According to the received surgical reports, the reported event can be confirmed.No product was returned for visual examination.This device is intended for treatment.Review of the device history records did not identify any deviations or anomalies during manufacturing.No further investigation required as this issue is known and addressed (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).Most likely root cause for the reported event is inappropriate use/implantation of the product.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 DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48¸ 42, CODE H
• Type of Device: HIP PROTHESIS
• 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: 17539461
• MDR Text Key: 321049905
• Report Number: 0009613350-2023-00451
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024422940
• UDI-Public: (01)00889024422940(17)091015(10)2234791
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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: 10/15/2009
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.048
• Device Lot Number: 2234791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2004
• 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; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 65 KG