MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. CUP W/HA PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1235-2-502

Device Problems Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Pain (1994); Tissue Damage (2104); Discomfort (2330); Complaint, Ill-Defined (2331); Peroneal Nerve Palsy (2362); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly following the implantation on (b)(6) 2012 the patient suffered from left hip pain, discomfort, immobility etc. And was revised on (b)(6) 2016. It is further alleged during the revision the surgeon noted "black staining in the soft tissues and thick gelatinous joint fluid. Some superficial notching in the superior posterior aspect of the femoral component back region. "the preoperative diagnosis was "left hip high output of wear, resulting in development of cyst compressing sciatic nerve" and the postoperative diagnosis was "metallosis due to impingement of the titanium femoral component with the rim of the cobalt chrome acetabular component resulting in increased development of joint fluid and development of the cyst".

• Brand Name: RESTORATION (TM) ADM. CUP W/HA
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6271229
• MDR Text Key: 65532935
• Report Number: 0002249697-2017-00289
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 1235-2-502
• Device Lot Number: G3010458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/23/2017 Patient Sequence Number: 1