MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0740
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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 or Problem Description
It was reported by patient's attorney as a result of a legal claim that allegedly on (b)(6) 2012 the patient was implanted with a stryker v40 femoral head on his right hip.It is further alleged "subsequently he developed progressive groin pain and right hip pain and a cobalt ion level that was extremely high.Due to this, revision was performed on (b)(6) 2019.".

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #7
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9221084
• Report Number: 0002249697-2019-03584
• Device Sequence Number: 14136704
• Product Code: LPH
• UDI-Device Identifier: 04546540510723
• UDI-Public: 04546540510723
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 6021-0740
• Device Lot Number: 22373201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR