MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 52/46 L DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12. 5 extended offset catalog#: 00771101220; unknown; lot#: 60746864, metasul® ldh®, head, 46, code l, taper 18/20 catalog#: 0100181460; lot#: 2397377, metasul® ldh®, head adapter, s, -4, taper 12/14-18/20 catalog#: 01. 00185. 145; lot#: 2414462. 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) legal department is well trained and passes all information concerning the case to our complaint handling department. As soon as supplemental information becomes available an updated report will be submitted. The manufacturer did not receive x-rays, or other source documents for review. Surgical reports were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. The lot number of the device was received. The device history records will be reviewed during investigation. 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

It was reported that failed left total hip replacement. Revision surgery. Left hip degenerative arthritis. Left tha. An aggressive synovectomy is necessary to dislocate the hip. The tissue had a brownish discoloration. With just a quarter turn pass, the cup was found to be grossly loose. There was no evidence of bony ingrowth.

• Brand Name: DUROM US ACET CMPNT 52/46 L
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• 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: 14101562
• MDR Text Key: 289176650
• Report Number: 0009613350-2022-00228
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/15/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00214.152
• Device Lot Number: 2395162
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2007
• 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 Treatment Data

Date Received: 04/13/2022 Patient Sequence Number: 1