MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HEAD; HIP IMPLANT

Catalog Number	6260-9-328
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/11/2011
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 reported discrepancies.There has been one other event for the lot referenced.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.Not returned.
Event or Problem Description
It was reported by the attorney that plaintiff underwent a total hip arthroplasty on (b)(6) 2010.Head was revised on (b)(6) 2011 and once again on (b)(6) 2011.This pi is for head revision 2.
Additional Manufacturer Narrative
Corrected data: d1 - product long description; d2 - product code, common device name; d4 - lot#; g1 - manufacturing site; h6 - method code.Catalog and lot# updated to "unknown." please disregard initially reported manufacturing date, expiration date, gtin, 510(k) an event regarding revision for unspecified reasons involving a head was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.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 the attorney that plaintiff underwent a total hip arthroplasty on (b)(6) 2010.Head was revised on (b)(6) 2011 and once again on (b)(6) 2011.*this pi is for head revision 2.

• Brand Name: UNKNOWN HEAD
• Common Device Name: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8272252
• Report Number: 0002249697-2019-00280
• Device Sequence Number: 13761629
• Product Code: JDI
• UDI-Device Identifier: 07613327013115
• UDI-Public: 07613327013115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 10/31/2015
• Device Catalogue Number: 6260-9-328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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