MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/-3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	06-2898
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	03/19/2019
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.
Event or Problem Description
Primary procedure, left bipolar hip.It was reported that after impacting the c-taper lfit head, the head was able to be removed from the trunnion using one finger.Surgeon removed the head, cleaned and dried it, re-impacted it with the same result.A second head was opened and performed as expected.Surgery was completed successfully with a delay of approximately 2 minutes.The rep might be able to obtain the operative report and reported that no further information will be released.
Event or Problem Description
Primary procedure, left bipolar hip.It was reported that after impacting the c-taper lfit head, the head was able to be removed from the trunnion using one finger.Surgeon removed the head, cleaned and dried it, re-impacted it with the same result.A second head was opened and performed as expected.Surgery was completed successfully with a delay of approximately 2 minutes.The rep might be able to obtain the operative report and reported that no further information will be released.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a metal head was reported.The event was not confirmed.Method & results product evaluation and results: visual inspection of the returned device noted the following: material analysis of the returned device noted the following: damage consistent with implantation process, based on the given information no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible 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/-3
• 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: 8518008
• Report Number: 0002249697-2019-01613
• Device Sequence Number: 16522908
• Product Code: LWJ
• UDI-Device Identifier: 07613327016284
• UDI-Public: 07613327016284
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K993601
• 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): 05/10/2019

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: 07/31/2023
• Device Catalogue Number: 06-2898
• Device Lot Number: 2N74P4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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