MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 4.5; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6020-4535
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Edema (1820); Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
The metal head was worn off and ruined the stems trunnion.Update 16/october/2018: rep listed the following adverse consequences: delay in surgery, metallosis, pseudotumor.
Additional Manufacturer Narrative
An event regarding disassociation involving an accolade stem was reported.The event was confirmed through x--ray and photographs of the explanted device.Method & results: product evaluation and results: no product was returned for evaluation, however photographs were provided for review.The photographs show a recently explanted stem and head.The neck/trunion of the stem is worn, there is also blackening on the stem.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray and photo confirms disassociation and trunion erosion/corrosion.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: x-ray and photo confirms disassociation and trunnion erosion/corrosion further information such as operative reports, patient demographics, past medical history and examination of explanted products are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The metal head was worn off and ruined the stems trunnion.Update (b)(6) 2018: rep listed the following adverse consequences: delay in surgery, metallosis, pseudotumor.

• Brand Name: ACCOLADE 132 SIZE 4.5
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8007110
• Report Number: 0002249697-2018-03514
• Device Sequence Number: 289152
• Product Code: LPH
• UDI-Device Identifier: 04546540510631
• UDI-Public: 04546540510631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 01/30/2013
• Device Catalogue Number: 6020-4535
• Device Lot Number: 25211901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: 70 YR