MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	06-2805
Medical Device Problem Codes	Component Incompatible (1108); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/30/2019
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
On (b)(6) 2019 revision surgery was performed due to bha migration.Bha was revised to tha.Intraoperatively, a c-taper head was used with a morse-taper stem by mistake without being noticed by anyone.2 days after the revision surgery, the head disassociation was found.The second revision was performed in the same day, the c-taper head was revised to a morse-taper head.
Event or Problem Description
On (b)(6) 2019 revision surgery was performed due to bha migration.Bha was revised to tha.Intraoperatively, a c-taper head was used with a morse-taper stem by mistake without being noticed by anyone.2 days after the revision surgery, the head disassociation was found.The second revision was performed in the same day, the c-taper head was revised to a morse-taper head.
Additional Manufacturer Narrative
An event regarding disassociation involving a metal head was reported.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Conclusion: it was reported that during surgery a c-taper head was used with a morse taper stem.2 days after the revision surgery, the head dissociation was found.Based on the provided information it has been determined that this event is associated with an off-label application.The ifu qin 4309 ver e which was packaged with the device states 'howmedica osteonics femoral bearing heads are available in morse taper and c-taper designs for use with howmedica osteonics femoral stems with respectively compatible trunnion tapers.C-taper heads must only be used with those howmedica osteonics stems which have a c-taper trunnion and are labeled accordingly.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: C-TAPER COCR LFIT HEAD 28MM/+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: 9130434
• Report Number: 0002249697-2019-03337
• Device Sequence Number: 19411433
• Product Code: LWJ
• UDI-Device Identifier: 07613327016277
• UDI-Public: 07613327016277
• Combination Product (Y/N): N
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: No Information
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 06-2805
• Device Lot Number: 525XT0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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