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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION (TM) ADM. CUP W/HA PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
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".
 
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Brand NameRESTORATION (TM) ADM. CUP W/HA
Type of DevicePROSTHESIS, 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 Key6271229
MDR Text Key65532935
Report Number0002249697-2017-00289
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072020
Number of Events Reported1
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 Received01/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2015
Device Catalogue Number1235-2-502
Device Lot NumberG3010458
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 Received10/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2010
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
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