MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6020-3535

Device Problems Corroded (1131); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 06/06/2022

Event Type  Injury  

Event Description

As reported: "patient arrived at hospital with a dislocated hip [femoral head dissociation]stem was removed trunnion corrosion and failure in monolithic metal was observed.An accolade 2 stem was implanted with new liner and +5mm 36mm ceramic head.No other parts were removed or revised." rep provided explant pictures and x-rays.Spoke to rep.Intra-operatively, damage to the rim of the liner was also noted.

Manufacturer Narrative

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 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.Device not returned.

Event Description

As reported: "patient arrived at hospital with a dislocated hip [femoral head dissociation]¿stem was removed trunnion corrosion and failure in monolithic metal was observed.An accolade 2 stem was implanted with new liner and +5mm 36mm ceramic head.No other parts were removed or revised." rep provided explant pictures and x-rays.Spoke to rep.Intra-operatively, damage to the rim of the liner was also noted.

Manufacturer Narrative

Reported event; an event regarding disassociation involving an accolade stem that mated with a metal head was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: no product was returned for evaluation however photographs were provided for review.The photographs show a recently explanted head, stem and liner.Blood is visible on all devices.Bony ingrowth is visible on the body of the stem.The trunnion is worn/corroded.Screws are visible in the liner most likely used for explantation purposes.Damage is visible on the rim of the liner.-clinician review: a review of the provided medical records by a clinical consultant indicated: again, as i described above this inquiry describes the failure of a total hip arthroplasty approximately 15 years after implantation due to femoral head disassociation and possible trunnion failure.Causes of this type of failure are multifactorial including surgical technique, patient factors and implant factors.The root cause of this event cannot be determined with certainty.An implant metallurgical analysis would have to be carried out to determine the exact mechanism of failure.-product history review: review of the device history records indicate the 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 lot referenced.Conclusions: it was reported that the patient was revised due to disassociation of the head from the stem.The event was confirmed by visual inspection of provided photographs of the devices and by review of the provided medical information by a clinical consultant.The reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE 132 SIZE 3.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; centennial park, elstree; limerick WD6 3-SJ ; EI WD6 3SJ ; 61498200
• MDR Report Key: 14874625
• MDR Text Key: 295037287
• Report Number: 0002249697-2022-00949
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510624
• UDI-Public: 04546540510624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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: 04/30/2012
• Device Model Number: 6020-3535
• Device Catalogue Number: 6020-3535
• Device Lot Number: 22154601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female