MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0330
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/16/2021
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.
Event or Problem Description
It has been reported "on (b)(6) 2021, the patient felt the click of her right hip while walking.She was unable to continue walking".As reported by the sales rep "as you can see on the complaint form there was implanted aesculap head (competitor's head) on a accolade stem".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and wear involving an accolade stem was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the trunnion of the stem is severely worn.The device has fractured at the point of wear.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned device.The device fractured in overload at the point of wear.No further material analyses were performed.-clinician review: no medical records were received for review with a clinical consultant.-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 accolade stem was revised due to the patient's loss of mobility.It was reported that the stem was implanted with a metal head from another manufacturer.Visual inspection of the returned device indicated that the trunnion of the stem is severely worn.The device has fractured at the point of wear.The exact cause of the event could not be determined.However, a review of the documentation, which was packaged with the device at the time of manufacture, indicated that the reported accolade stem is only compatible with stryker-manufactured heads and sleeves: "do not substitute another manufacturer¿s device for any component of the how medica osteonics total hip system.Any such use will negate the responsibility of how medica osteonics corp.For the performance of the resulting mixed component implant." the user's intentional off-label use of the device likely contributed to the device failure.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It has been reported "on (b)(6) 2021, the patient felt the click of her right hip while walking.She was unable to continue walking" as reported by the sales rep "as you can see on the complaint form there was implanted aesculap head (competitor's head) on a accolade stem".

• Brand Name: SIZE 3 ACCOLADE II 132 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 11642625
• Report Number: 0002249697-2021-00655
• Device Sequence Number: 3160493
• Product Code: LPH
• UDI-Device Identifier: 04546540664464
• UDI-Public: 04546540664464
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2022

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: 08/31/2021
• Device Model Number: 6720-0330
• Device Catalogue Number: 6720-0330
• Device Lot Number: 56538703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 03/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG