MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 52/ 46, CODE L

Model Number N/A

Device Problems Biocompatibility (2886); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01.00185.145; lot#: unknown.Metasul ldh, head, 46, code l, taper 18/20; catalog#: 01.00181.460; lot#: unknown.Therapy date: unknown.The manufacturer did not receive devices, x-rays, or other source documents for review, as the patient is currently being monitored and has not been revised to date.As no lot numbers were provided for the devices, the device history records could not be reviewed.The cause for this specific event cannot be ascertained from the information provided, as the patient has not been revised.The common clinical presentation and the date of the original implantation suggest that this case might be related to the issues for which zimmer implemented a notification in july 2008 as referenced.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result is available, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the left side and started experiencing pain.Patient is confined to the wheelchair as the pain is unbearable.The patient has not been revised yet.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Dhr review: the device history records were reviewed and found to be conforming.Review of event description: patient was implanted on left side and experienced pain after the implantation.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 (b)(4) (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.Should any additional information that changes the assessment become available to us, or any extra demand be requested, we will re-evaluate the case.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 52/ 46, CODE L
• Type of Device: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10747603
• MDR Text Key: 213426017
• Report Number: 0009613350-2020-00512
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.052
• Device Lot Number: 2362837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization