MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6721-0330

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 10/22/2020

Event Type  Injury  

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

Event Description

Marchand revised a femoral head due to a calcar fracture of a left hip.(primary) originally done 2-days ago on (b)(6) 2020.He added dall-miles cables to repair the fracture.The patient fractured their femur on day 1 post-op during physical therapy.Update 22/october/2020 wg: rep provided a pre-revision x-ray, primary and revision usage sheets, and reported that no further information will be released due to hospital policy.

Event Description

Marchand revised a femoral head due to a calcar fracture of a left hip.(primary) originally done 2-days ago on (b)(6) 2020.He added dall-miles cables to repair the fracture.The patient fractured their femur on day 1 post-op during physical therapy.Update (b)(6) 2020 wg: rep provided a pre-revision x-ray, primary and revision usage sheets, and reported that no further information will be released due to hospital policy.

Manufacturer Narrative

Reported event an event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed via clinician review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-rays show a displaced calcar fracture requiring orif with cerclage cables which reportedly was subsequently performed.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 21-aug-2020 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: clinician review indicated that provided x-rays show a displaced calcar fracture requiring orif with cerclage cables which reportedly was subsequently performed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports 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 become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 3 ACCOLADE II 127 DEG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10841556
• MDR Text Key: 216317188
• Report Number: 0002249697-2020-02453
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540669483
• UDI-Public: 04546540669483
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• 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: 12/22/2020

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 Model Number: 6721-0330
• Device Catalogue Number: 6721-0330
• Device Lot Number: 77686402
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/15/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR