MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6720-0837
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Reaction (2414); Ambulation or Postural Difficulties (2544)
Date of Event	12/16/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding pain involving an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated, "x-ray printouts include a series dated (b)(6) 2016, which is an ap of the pelvis and an ap and lateral of the left hip, demonstrating bilateral uncemented total hip arthroplasties with one screw in the right acetabulum and none in the left.All components are reduced and in nominal position.No gross pathology is noted.Communication from stryker orthopaedics indicates none of the components implanted in this patient¿s hips were subject to a recall.Based upon the information available for review, there is no indication this patient¿s complaints are related to factors of faulty total hip arthroplasty components design, manufacturing or materials." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been ono other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Pain can occur post-operatively for a number of reasons and is a symptom rather than the cause of the issue the patient is experiencing.Communication from stryker orthopaedics indicates none of the components implanted in this patient¿s hips were subject to a recall.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.
Event or Problem Description
Patient stated he was experiencing a lot of problems with his left hip implant.Patient wants to know if implants are part of recall update: patient is experiencing chronic pain.He has to use a wheel chair when he walks for a long period of time.Update: it was reported by the attorney that plaintiff underwent a total hip arthroplasty on (b)(6) 2013 and had to undergo revision surgery on (b)(6) 2017 of the lfit v40 head due to alleged altr.

• Brand Name: SIZE 8 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: 8460883
• Report Number: 0002249697-2019-01466
• Device Sequence Number: 3057217
• Product Code: LPH
• UDI-Device Identifier: 04546540664518
• UDI-Public: 04546540664518
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 6720-0837
• Device Lot Number: 41765007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/28/2019
• 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 Age: 64 YR
• Patient Weight: 84