MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	06-3600
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
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 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.Device not returned.
Event or Problem Description
As reported: "surgeon tried to implant stem and impact head onto stem.C-taper metal head did not engage onto the trunnion of the c-taper hfx stem.Head just spun on trunnion".A surgical delay of 5 minutes was reported.A usage sheet provided by the rep shows a 36 +0 c-taper head with "no charge", and a 36 +2.5 c-taper head with no note placed afterward.
Additional Manufacturer Narrative
An event regarding as assembly issue (c-taper metal head did not engage onto the trunnion of the c-taper hfx stem.Head just spun on trunnion) the reported issue was not confirmed.Method & results: -device evaluation and results: the metal head was returned for evaluation.Implantation damage was observed on the inner taper of the head, no materials or manufacturing defects were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-device 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.Conclusion: the metal head was returned for evaluation.Implantation damage was observed on the inner taper of the head, no materials or manufacturing defects were observed on the surfaces examined.The event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as images/video of the device taken when the alleged event was identified as well as the primary operative report are required to complete the investigation for confirming the event and determining a root cause.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: "surgeon tried to implant stem and impact head onto stem.C-taper metal head did not engage onto the trunnion of the c-taper hfx stem.Head just spun on trunnion".A surgical delay of 5 minutes was reported.A usage sheet provided by the rep shows a 36 +0 c-taper head with "no charge", and a 36 +2.5 c-taper head with no note placed afterward.

• Brand Name: C-TAPER COCR LFIT HEAD 36MM/0
• 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: 8821679
• Report Number: 0002249697-2019-02650
• Device Sequence Number: 3258347
• Product Code: JDI
• UDI-Device Identifier: 07613327072365
• UDI-Public: 07613327072365
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: 05/31/2022
• Device Catalogue Number: 06-3600
• Device Lot Number: J47LT1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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: Other
• Patient Age: 73 YR
• Patient Weight: 94