MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-226
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As the patient who took effect at tha on (b)(6) 2003 repeated dislocation, replaced on the cup side on (b)(6) 2018.When the head was pulled out, the trunnion insertion part of the head was discolored black.Remained the stem as it was.
Additional Manufacturer Narrative
An event regarding dislocation of the head and corrosion on the head taper involving a metal head was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection was performed on the returned head; damage was observed on the distal surface of the head, consistent with contact against a hard object; taper of the head has debris.Material analysis was performed on the debris that was in the taper which concluded: debris was observed on the taper of the head.Eds showed the head was consistent with astm f1537 alloy and the debris was consistent with an oxide formation, a corrosion product, a stem base alloy and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: no medical records were received for review with a clinical consultant -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the reported event regarding dislocation cannot be confirmed as medical records were not provided for review.Visual inspection was performed on the returned head; damage was observed on the distal surface of the head, consistent with contact against a hard object; taper of the head has debris.Material analysis was performed on the debris that was in the taper which concluded: debris was observed on the taper of the head.Eds showed the head was consistent with astm f1537 alloy and the debris was consistent with an oxide formation, a corrosion product, a stem base alloy and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, histopathology reports and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
As the patient who took effect at tha on (b)(6) 2003 repeated dislocation, replaced on the cup side on (b)(6) 2018.When the head was pulled out, the trunnion insertion part of the head was discolored black.Remained the stem as it was.

• Brand Name: 26MM +4 V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8026257
• Report Number: 0002249697-2018-03567
• Device Sequence Number: 11107756
• Product Code: JDI
• UDI-Device Identifier: 07613327012880
• UDI-Public: 07613327012880
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 08/31/2008
• Device Catalogue Number: 6260-5-226
• Device Lot Number: 6596701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 02/28/2019
• 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