MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SUPER SECUR-FIT 127 DEGREE SIZE 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number J6052-0830

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

There were some areas where the tissue was discolored black during the removal operation, and there were findings like armd.Check to see if there was any impingement on the shell and stem neck, and if there are any scratches on the stem neck.No visible damage to the stem neck was found during surgery.Update: "loosening, suspected infection.Intraoperative examination showed no infection.".

Event Description

There were some areas where the tissue was discolored black during the removal operation, and there were findings like armd.Check to see if there was any impingement on the shell and stem neck, and if there are any scratches on the stem neck.No visible damage to the stem neck was found during surgery.Update: "loosening, suspected infection.Intraoperative examination showed no infection.".

Manufacturer Narrative

Reported event: an event regarding damage and fretting involving a securfit stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 23 november 2020 this inspection indicated: biological material was observed on the porous surfaces of posterior and lateral faces of the stem).Damage consistent with the explantation process was observed on the stem.A material analysis has been performed.The report concluded: discoloration observed on the trident psl shell was consistent with oxidation.Damage on the returned stem is consistent with the explantation process.Damage on the inner taper of the head was consistent with interaction with the stem trunnion.Damage on the articulating surface of the crossfire insert was consistent with burnishing and scratching which are common damage modes of uhmwpe.The yellow discoloration observed on the insert was consistent with the absorption of synovial fluid.The eds analyzes showed that the shell component coating and base material were consistent with the drawing, the region of discoloration was consistent with oxidation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: which is from japan and represents a female patient whose date of implantation is listed as (b)(6) 2006 and explantation (b)(6) 2020.The event description states: ".Some areas where the tissue was discolored black during the removal operation.Findings like armd.No visible damage to the stem neck was found during surgery." 3 undated, unlabeled images: ap and lat.X-ray and ap ct cut of right hip demonstrating uncemented right tha with 4 screws in the acetabular shell, reduced with radio lucencies around acetabular component in all 3 charnley zones.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no surgical pathology reports.Based upon the 3 images supplied for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.  complaint history review: there have been no other similar events for the reported lot.    conclusion: 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 clinical or patient medical history, patient demographics, operative reports, examination of explanted components and surgical pathology reports are required to complete the investigation for 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.

• Brand Name: SUPER SECUR-FIT 127 DEGREE SIZE 8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10480221
• MDR Text Key: 205268512
• Report Number: 0002249697-2020-01781
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327101768
• UDI-Public: 07613327101768
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Model Number: J6052-0830
• Device Catalogue Number: J6052-0830
• Device Lot Number: 17609403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention