MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 40MM 127° NECK TRIAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1020-2740
Medical Device Problem Code	Delamination (2904)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Color marking from the rasps crumble off.Replacement was available.
Additional Manufacturer Narrative
Additional information: device evaluated by mfg.An event regarding crack/fracture involving an accolade neck was reported.The event was confirmed by product inspection.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 14-mar-2018 which indicated the macroscopic fracture morphologies observed on the fracture surface of the neck indicators are consistent with a fracture due to multiple overload events.The mar report concluded: the neck indicator fractured in multiple overload events.Clinician review: not performed as no medical records were provided and patient factors did not contributed to the event findings.Product history review: a review of the product history review indicated the devices accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per material analysis performed on the returned product which concluded that the neck indicator fractured in multiple overload events.No identifiable material or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If the additional information is received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Color marking from the rasps crumble off.Replacement was available.

• Brand Name: ACCOLADE 40MM 127° NECK TRIAL
• 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: 7569215
• Report Number: 0002249697-2018-01699
• Device Sequence Number: 2527086
• Product Code: LPH
• UDI-Device Identifier: 07613327208122
• UDI-Public: 07613327208122
• Combination Product (Y/N): N
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1020-2740
• Device Lot Number: P16K29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/29/2018
• 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: Other