MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/140 N/A

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. As no lot number was provided, the device history records could not be reviewed. An e-mail requesting the following additional information was sent to the appropriate representatives: please clarify the correct notification date: is it the 14. 10. 2019 or 15. 10. 2019. Ref: (b)(4) please provide us the lot number. Exact implant date. Implantation report. Revision report. All available x-rays during time in- vivo with printed date. All available intraoperative pictures. Patient dob, weight, height, bmi and all relevant history. Did a delay in the procedure occur that was related to the event? if yes, time surgery was extended? were there any contributing conditions related to the event? (ex: trauma, illness, previous surgery, related non-compliance, patient anatomy) was the surgical technique for the product utilized? concomitant medical product: unknown revitan distal stem hip, item#: unknown, lot#: unknown. 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. (b)(4).

Event Description

It was reported that product was implanted in 2006 and revised due to pain and implant fracture.

• Brand Name: REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/140
• Type of Device: N/A
• 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: 9250355
• MDR Text Key: 164263968
• Report Number: 0009613350-2019-00637
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/15/2008
• Device Model Number: N/A
• Device Catalogue Number: 01.00406.120
• Device Lot Number: 2192419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 10/29/2019 Patient Sequence Number: 1