MAUDE Adverse Event Report: ZIMMER GMBH DUROM US ACETABULAR COMPONENT 58/52 R; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problems Material Erosion (1214); Defective Device (2588)

Patient Problems Failure of Implant (1924); Pain (1994); Reaction (2414)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date detail of product: item number 0100185145, item name metasul ldh, head adapter, s, -4, taper 12/14-18/20, lot # 2365320.Item number 0100181520, item name metasul ldh, head, 52, code r, taper 18/20, lot # 2359057.The manufacturer did not receive devices or x-rays for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.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.Therefore, zimmer (b)(4) considers this case as closed.(b)(4).

Event Description

It was reported that patient underwent revision surgery due to pain and difficulty ambulating.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: additional: h2.Correction: a1 - b4 - b5 - e1 - g4 - g7 - h6 - h10.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

In addition to the report , patient pursuing a product liability claim becasue underwent revision surgery due to also elevated metal ions levels, non ingrowth of the acetabular cup, periarticular lysis with fluid collection and capsular dehiscence, stained serous fluid with metal stained synovium, moderate hypertrophy, heterotopic ossification.Significant corrosion at the adapter head function was identified intra-operatively.

• Brand Name: DUROM US ACETABULAR COMPONENT 58/52 R
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8477503
• MDR Text Key: 140732301
• Report Number: 0009613350-2019-00183
• 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: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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: 01/15/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.158
• Device Lot Number: 2357488
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 07/11/2019
• 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
• Patient Weight: 83