MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-232
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Injury (2348); Reaction (2414)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The patient underwent tha surgery with centpillar on (b)(6) 2009.The patient claimed abnormal sound from the left hip and a dislocation of the metal head was confirmed.Revision surgery was performed on (b)(6) 2018, and an insert, the metal head and the stem were replaced.Wear of the stem neck was noticed.Also, inside of the patient's hip joint was black by metal abrasion powder.
Additional Manufacturer Narrative
An event regarding wear, altr & disassociation involving a metal head was reported.The event of wear and disassociation was confirmed.Altr was not confirmed.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar).Damage was also observed on the taper of the head, likely from interacting with the trunnion of the stem.Debris was also observed on the taper of the head.Dimensional & functional inspection: not performed as there is evidence from the visual inspection that the device is damaged.Material analysis: a material analysis has been performed.The report concluded: damage was observed on the stem trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and stem trunnion losing their taper lock.Debris was observed in the taper of the head.Eds showed the stem and head chemistries were consistent with their drawing callouts and the debris was consistent with a corrosion product, biological material, material transfer from the stem, and an oxide.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirms dissociation of the femoral head from the trunnion of the femoral stem with subsequent damage to the trunnion and head occurred.These events were caused by failure the taper lock between the head and trunnion.-device 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.Conclusion: the clinician confirmed.These events were caused by failure the taper lock between the head and trunnion, however, the root cause could not be determined.
Event or Problem Description
The patient underwent tha surgery with centpillar on(b)(6) 2009.The patient claimed abnormal sound from the left hip and a dislocation of the metal head was confirmed.Revision surgery was performed on (b)(6) 2018 ,and an insert, the metal head and the stem were replaced.Wear of the stem neck was noticed.Also, inside of the patient's hip joint was black by metal abrasion powder.

• Brand Name: 32MM +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: 7597103
• Report Number: 0002249697-2018-01798
• Device Sequence Number: 16440866
• Product Code: JDI
• UDI-Device Identifier: 07613327012903
• UDI-Public: 07613327012903
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 10/24/2018

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 Catalogue Number: 6260-5-232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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: 61 YR
• Patient Weight: 118