MAUDE Adverse Event Report: ZIMMER GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Depression (2361)

Event Type  Injury  

Manufacturer Narrative

Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) (b)(6) legal department is well trained and passes all information concerning the case to our complaint handling department.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.Review of event description: patient is medically precluded due to chronic pain.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 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 reevaluate the case.Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation.Zimmer¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2018-00509, 0009613350-2018-00510, 0009613350-2018-00511.

Event Description

A patient is pursuing a product liability claim.It was reported that the patient is medically precluded due to chronic pain after total hip arthroplasty.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
• 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
• Manufacturer (Section G): ZIMMER 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: 7509911
• MDR Text Key: 108093611
• Report Number: 0009613350-2018-00508
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/14/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.050
• Device Lot Number: 2479183
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2008
• 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: CLS SPOTORNO STEM, ITEM# 29.00.39-080, LOT# 2501228; METASUL ADAPTER, ITEM# 01.00185.146, LOT# 2494478; METASUL HEAD, ITEM# 01.00181.440, LOT# 2481324
• Patient Outcome(s): Other