MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 2 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0230
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/01/2014
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.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.The following devices were also listed in this report: unitrax modular endo head 43mm; cat# 6942-5-043; lot# mlr4y1; unitrax v40 sleeve -4mm; cat# 6942-6-060; lot# 39664802.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Postoperative diagnosis: patient underwent left hip hemi arthroplasty for femoral neck fracture (b)(6) 2014.Patient returned to have revision arthroplasty with insertion of antibiotic beads for hip infection (b)(6) 2014.All components exchanged.
Additional Manufacturer Narrative
An event regarding infection involving a accolade stem was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: 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.There has been 1 other similar event for the sterile lot referenced.A review of both the sterilization data and microbiology data was performed for this sterile lot commonality.It was identified that the sterilization data was within specification and no microbiology excursions were noted for this lot and as such no further review is required.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: unitrax modular endo head 43mm; cat# 6942-5-043; lot# mlr4y1.Unitrax v40 sleeve -4mm; cat# 6942-6-060; lot# 39664802.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Postoperative diagnosis: patient underwent left hip hemi arthroplasty for femoral neck fracture (b)(6) 2014.Patient returned to have revision arthroplasty with insertion of antibiotic beads for hip infection (b)(6) 2014.All components exchanged.

• Brand Name: SIZE 2 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
• MDR Report Key: 8352331
• Report Number: 0002249697-2019-01096
• Device Sequence Number: 16701565
• Product Code: LPH
• UDI-Device Identifier: 04546540664457
• UDI-Public: 04546540664457
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 11/30/2017
• Device Catalogue Number: 6720-0230
• Device Lot Number: 41861509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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 Weight: 68