MAUDE Adverse Event Report: ZIMMER, INC. METASUL SHELL; HIP PROSTHESIS

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Compatibility Problem (2960)

Patient Problems Pain (1994); Reaction (2414)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion to the cause of the event.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Event Description

Legal counsel for patient reported patient had a left hip revision approximately 8 years post implantation due to cup loosening, pain, elevated metal ion levels consistent with metallosis.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Revision operative report notes loosening of the acetabular cup, malpositioned femoral stem, metallosis, cyst formation, black granulation tissue, and pseudotumor.

Manufacturer Narrative

Upon receipt of additional information, it was determined that this event should not have been reported under this mfr number.The initial report should be voided and a new report has been filed under (b)(6) mfr 9613350-2016-00962.

• Brand Name: METASUL SHELL
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6378733
• MDR Text Key: 69100810
• Report Number: 0001822565-2017-01496
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 0100214158
• Device Lot Number: 2341984
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 111