MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 7 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0737
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Reaction (2414)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that during revision of an accolade 2 stem, 36mm+5 head, trident cup when head was removed from stem there were black debris noticed on stem trunion and in the femoral head.
Additional Manufacturer Narrative
Reported event: an event regarding fretting and corrosion involving a accolade stem was reported.The event of fretting and corrosion was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection of the returned device noted the following: visual inspection was performed as part of the material analysis report mar.Biological material was observed on the porous coating of the stem.Debris was observed on the stem trunnion, a material analysis report was completed.The debris on the stem trunnion was consistent with a corrosion product, and oxide, and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection of the returned device noted the following: visual inspection was performed as part of the material analysis report mar.Biological material was observed on the porous coating of the stem.Debris was observed on the stem trunnion, a material analysis report was completed.The debris on the stem trunnion was consistent with a corrosion product, and oxide, and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays 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 becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that during revision of an accolade 2 stem, 36mm+5 head, trident cup when head was removed from stem there were black debris noticed on stem trunion and in the femoral head.

• Brand Name: SIZE 7 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
• MDR Report Key: 10216703
• Report Number: 0002249697-2020-01342
• Device Sequence Number: 14113740
• Product Code: LPH
• UDI-Device Identifier: 04546540669520
• UDI-Public: 04546540669520
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 6721-0737
• Device Catalogue Number: 6721-0737
• Device Lot Number: 51995004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR