MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 56/50 P; DUROM ACETABULAR COMPONENT AND METASUL LDH

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Metal Related Pathology (4530)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

Medical product: metasul ldh, head, 50, code p, taper 18/20; catalog no#: 01.00181.500; lot#: 2342284.Therapy date: (b)(6) 2020.The manufacturer received legal note, surgical reports, surgical pathology and lab reports for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to elevated metal ion levels.

Event Description

No event update.Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6, correction: b4, b5, g3, g6, h10.Dhr review: the quality records indicate that this component met all requirements to perform as intended.Review of event description: patient was implanted on an right side and underwent revision due to elevated metal ion levels.Surgical report: review of surgical report did not lead to new information regarding the reported event.Other information & sources: review of the complaint relevant documents did not lead to new information regarding the reported event.No further "due diligence" required as all required information to support the conclusion is available/was already requested.Complex physiological reactions like pseudotumor or metal allergy are known risks for this kind of metal-on-metal implants as stated in zimmer¿s instruction leaflet for endoprothesis.Conclusion: no further investigation required as this issue is known and addressed in wt123080 (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced above in h7 and h9.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: DUROM US ACET CMPNT 56/50 P
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10868557
• MDR Text Key: 217151664
• Report Number: 0009613350-2020-00541
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.156
• Device Lot Number: 2333361
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9613350-07/15/2008-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention