MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0535
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Purulent Discharge (1812); Fall (1848); Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Additional 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.The following devices were also listed in this report: delta v-40 ceramic head 28/0; cat#6570-0-128; lot#86884504.Restoration adm x3 ins 28/48; cat#1236-2-848; lot#83844401.Modular dual mobility insert; cat#626-00-42e; lot#83990102.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.
Event or Problem Description
Patient had revision surgeon after presenting in emergency 2/52 post op following a fall.Patient has a peri prosthetic fracture of the femur.Restoration modular stem implanted, acetabular liner changed.Dall miles cables applied to fracture site.Right side.Update (b)(6) 2021: response noted: "was it noted why a culture examination was required? there small area of ooze noted at the distal end of the wound".
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture, subsidence and patient factors (drainage) involving a accolade stem was reported.The event of periprosthetic fracture and subsidence was confirmed via clinician review.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: the photo presented a recently explanted stem with blood and tissue on it.There is nothing else remarkable to report.-clinician review: a review of the provided medical records by a clinical consultant indicated: revision surgery for a tha peri-prosthetic fracture is confirmed.Although there was suspicion of infection no documentation was provided to verify this issue was presented.The root cause of the fracture was documented to be a fall.If additional information should become available i would be happy to further this assessment.-product history review: review of the device history records indicate 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's hip was revised due to an oblique fracture of the proximal femur following a fall and stem subsidence.Note was also made of drainage from the distal pole of the incision.The event of periprosthetic fracture and subsidence was confirmed via clinician review.Per clinician review the root cause of the fracture was documented to be a fall.The exact cause of subsidence and drainage could not be determined.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.
Event or Problem Description
Patient had revision surgeon after presenting in emergency 2/52 post op following a fall.Patient has a peri prosthetic fracture of the femur.Restoration modular stem implanted, acetabular liner changed.Dall miles cables applied to fracture site.Right side update 7 dec 2021: response noted: "was it noted why a culture examination was required? there small area of ooze noted at the distal end of the wound".Update on 24 mar 2022 per clinician review: " the ap/lateral x-rays of the right tha from the er demonstrate the peri-prosthetic fracture with subsidence of the stem.

• Brand Name: SIZE 5 ACCOLADE II 127 DEG
• Common Device Name: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13102528
• Report Number: 0002249697-2021-02089
• Device Sequence Number: 3510817
• Product Code: LPH
• UDI-Device Identifier: 04546540669506
• UDI-Public: 04546540669506
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: 6721-0535
• Device Catalogue Number: 6721-0535
• Device Lot Number: 87942602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female