MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 32MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	06-3205
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414)
Date of Event	09/06/2018
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 have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: "patient dislocated his primary implant due to aseptic loosening caused by metallosis created from the trunnion and the headball.The headball eventually disassociated from the stem in vivo.Patient required revision surgery".
Additional Manufacturer Narrative
An event regarding disassociation and metallosis involving a metal head was reported.The reported event for the disassociation was confirmed by material analysis of the returned device.Method & results: product evaluation and results: visual inpection of the returned device revealed: damage was observed on the distal rim of the head, consistent with contact against a hard object.The taper of the head is shown with damage being observed.This damage was likely from the interaction between the head taper and the trunnion.A detailed image of the proximal end of the taper is shown, with a step being observed.Debris was also observed at the proximal end of the head taper.A sample of the debris was placed on a scanning electron microscope (sem) stub for further analysis.A dimensional analysis of the device showed that the taper height and tooling clearance are within specifications per the drawing cd-06-2200, version s.See dimensional inspection results.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the reported event for disassociation was confirmed.A material analysis was performed and concluded "damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock." however, the root cause could not be determined as insufficient medical records were provided.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "patient dislocated his primary implant due to aseptic loosening caused by metallosis created from the trunnion and the headball.The headball eventually disassociated from the stem in vivo.Patient required revision surgery".

• Brand Name: C-TAPER COCR LFIT HEAD 32MM/+5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7934370
• Report Number: 0002249697-2018-03192
• Device Sequence Number: 941358
• Product Code: LWJ
• UDI-Device Identifier: 07613327016321
• UDI-Public: 07613327016321
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• 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): 02/19/2019

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: 03/31/2011
• Device Catalogue Number: 06-3205
• Device Lot Number: 22LMCA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 02/19/2019
• 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: 76 YR
• Patient Weight: 108