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

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2017

Event Type  malfunction  

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 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.

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 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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6724724
• MDR Text Key: 80421561
• Report Number: 0002249697-2017-02232
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07613327016260
• UDI-Public: 07613327016260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other