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

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

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 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 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.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8518008
• MDR Text Key: 142274382
• Report Number: 0002249697-2019-01613
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07613327016284
• UDI-Public: 07613327016284
• Combination Product (y/n): N
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 95 YR