MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	06-2800
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
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
After impacting the femoral head, the surgeon went to reduce the hip and the inner c-taper came off the trunnion of the stem.That left the head/bipolar component in the socket.A new head/bipolar component were used successfully.
Additional Manufacturer Narrative
An event regarding disassociation involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis report of the returned device indicated that "damage consistent with explantation process observed on articulating surface.Damage consistent contact against stem trunnion observed on taper." medical records received and evaluation: not performed as medical records were not provided.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: it is reported that during surgery the inner c-taper came off the trunnion of the stem and that left the head/bipolar component in the socket.The event could not be confirmed.Material analysis report of the returned device indicated that "damage consistent with explantation process observed on articulating surface.Damage consistent contact against stem trunnion observed on taper." the exact root cause could not determined.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
After impacting the femoral head, the surgeon went to reduce the hip and the inner c-taper came off the trunnion of the stem.That left the head/bipolar component in the socket.A new head/bipolar component were used successfully.

• Brand Name: C-TAPER COCR LFIT HEAD 28MM/0
• 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: 6724724
• Report Number: 0002249697-2017-02232
• Device Sequence Number: 19149255
• Product Code: LWJ
• UDI-Device Identifier: 07613327016260
• UDI-Public: 07613327016260
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2020
• Device Catalogue Number: 06-2800
• Device Lot Number: PE2KD0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: Other