MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-5537

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Integrity Problem (2978); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414); No Information (3190)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Revision hip done from head and stem broke.

Manufacturer Narrative

Reported event: an event regarding wear involving an accolade stem was reported.The event was confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who confirmed the disassociation and image of the stem showed significant trunnion wear with provided undated x-rays but deemed the information insufficient and rejected it for a medical review.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the consulting clinician confirmed the trunnion wear with provided images but the root cause could not be determined because the insufficient information was provided.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Revision hip done from head and stem broke.

Event Description

Revision hip done from head and stem broke.Patient had an incident with stryker product and had to go to emergency room, then to surgery.No control of left leg, unable to bear weight.Fracture of trunnion and tritanium head.Update per medical review: "the head is in the acetabulum and the trunnion is disassociated from the head and dislocated from the head.".

Manufacturer Narrative

An event regarding alleged disassociation involving an accolade stem was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as device not returned.-medical records received and evaluation: a review by a clinical consultant noted: "on (b)(6) 2016 a revision of the left total hip arthroplasty with proximal femoral osteotomy and open reduction/internal fixation was performed for a ¿failed left thr¿.The operative report describes general anesthesia and a posterolateral approach.The report notes, ¿ten years status-post left tha.Did well until two days ago ¿ blackening consistent with marked metallosis secondary to fractured stem ¿ stem solidly anchored in the femur ¿ femoral head was displaced and removed ¿ zimmer shell¿.There is no examination of the explanted components, no photographs of the explanted components, and no documented follow-up between (b)(6) 2007 and (b)(6) 2016, but the revision operative report states he ¿did well¿ during this period.Based upon the information available for review, no determination can be made regarding the cause of the clinical event requiring left total hip arthroplasty revision nine and three-quarters years post-implantation.The mismatched manufacturing source of the acetabular component may have increased the potential for stem impingement which might have contributed to the disassociation." -device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the reported event was confirmed however the root cause could not be determined due to insufficient information provided.Review of medical records by a consulting clinician indicated: "on (b)(6) 2016 a revision of the left total hip arthroplasty with proximal femoral osteotomy and open reduction/internal fixation was performed for a ¿failed left thr¿.The operative report describes general anesthesia and a posterolateral approach.The report notes, ¿ten years status-post left tha.Did well until two days ago ¿ blackening consistent with marked metallosis secondary to fractured stem ¿ stem solidly anchored in the femur ¿ femoral head was displaced and removed ¿ zimmer shell¿ there is no examination of the explanted components, no photographs of the explanted components, and no documented follow-up between (b)(6) 2007 and (b)(6) 2016, but the revision operative report states he ¿did well¿ during this period.Based upon the information available for review, no determination can be made regarding the cause of the clinical event requiring left total hip arthroplasty revision nine and three-quarters years post-implantation.The mismatched manufacturing source of the acetabular component may have increased the potential for stem impingement which might have contributed to the disassociation." based on the catalog and lot code provided, the stem is not subject to a recall.No further investigation is possible at this time.If if further information becomes available, this investigation will be re-opened.

• Brand Name: ACCOLADE (127 DEG) SIZE 5.5
• 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: 6080059
• MDR Text Key: 59203426
• Report Number: 0002249697-2016-03467
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Catalogue Number: 6021-5537
• Device Lot Number: 16895801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/04/2016
• Supplement Dates Manufacturer Received: Not provided; 01/31/2018
• Supplement Dates FDA Received: 01/26/2017; 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 84