MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0537

Device Problems Material Deformation (2976); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 08/31/2018

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

It was reported that patient's hip was revised due to disassociation of the head from the stem.Patient had complained of clicking for the month prior.Intraoperatively, no black tissue was noted, but the trunnion was worn to a perceptible cone.The head and stem were revised to a restoration modular stem construct and a metal head (liner was not revised).

Manufacturer Narrative

An event regarding dissassociation and wear involving an accolade stem was reported.Disassociation and wear were both confirmed following a clinician review.Device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: " x-ray confirms disassociation and trunnion erosion; need operative reports, clinical and past medical history and examination of explanted components." all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported.Conclusion: a review by a linical consultant noted, "x-ray confirms disassociation and trunnion erosion; need operative reports, clinical and past medical history and examination of explanted components." no further investigation for this event is possible at this time.Additional information, including operative reports, clinical and past medical history and examination of explanted components are needed to fully investigate the event.If further information becomes available and/or the product is returned, this investigation will be re-opened.

Event Description

It was reported that patient's hip was revised due to disassociation of the head from the stem.Patient had complained of clicking for the month prior.Intraoperatively, no black tissue was noted, but the trunnion was worn to a perceptible cone.The head and stem were revised to a restoration modular stem construct and a metal head (liner was not revised).

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #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: 7918546
• MDR Text Key: 122032959
• Report Number: 0002249697-2018-03117
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2009
• Device Catalogue Number: 6021-0537
• Device Lot Number: 9843602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/25/2018
• Supplement Dates FDA Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention