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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRITANIUM ACETABULAR CUP HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRITANIUM ACETABULAR CUP HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES Back to Search Results
Catalog Number UNK_JR
Device Problem Migration (4003)
Patient Problem Discomfort (2330)
Event Date 12/04/2019
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 through the filing of a lawsuit that allegedly on (b)(6) 2015 the patient was implanted with a tritanium acetabular cup on his right hip and a period of time after implantation began experiencing discomfort. It is alleged that in light of worsening symptoms he was first taken back to surgery on (b)(6) 2016 for right iliopsoas fractional lengthening, acetabular osteoplasty and extensive synovectomy due to iliopsoas impingement, synovitis and acetabular osteophyte. It is further alleged that he continued to suffer from persistent pain in his right hip and subsequent radiological workup demonstrated loosening of the acetabular component. He was revised on (b)(6) 2019 and allegedly during the revision surgery was found to have gross loosening of the acetabular cup.

 
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Brand NameUNKNOWN TRITANIUM ACETABULAR CUP
Type of DeviceHIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10566704
MDR Text Key207938059
Report Number0002249697-2020-01965
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 09/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2020
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

Patient TREATMENT DATA
Date Received: 09/22/2020 Patient Sequence Number: 1
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