MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-5537

Device Problems Corroded (1131); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Injury (2348); Reaction (2414)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that the patient has primary surgery in 2012.The patient presented in the last year with left thigh pain.The customer reported that cobalt and chromium levels are abnormal and that inflammation markers are normal.There were no obvious abnormalities on x-ray.Revision surgery was undertaken on (b)(6) 2016.

Manufacturer Narrative

Returned to manufacturer on: 10/26/2016.An event regarding pain and corrosion involving an accolade stem was reported.The event was confirmed.Method & results: -device evaluation and results: discoloration was observed in the taper of the head.Eds showed the head was consistent with a cocr alloy and the discoloration was consistent with material transfer from a hip stem, a corrosion process and biological material.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: review of medical records by a consulting clinician indicated: "the primary harm involved is pain following a pressfit tha.Detailed material analysis found no defect in the manufacturing of the implant.Discoloration of the implants consistent with corrosion was identified.Some degree of corrosion is seen in all stem/head constructs of dissimilar metals.The amount and degree of corrosion was not quantified as to a reference to the expected norm.It can not be determined if the corrosion seen had any causative relationship to the patients pain." -device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been one other event for the reported lot.Conclusions: the event description indicates that the reason for revision of the hip was due to pain and high cobalt chrome levels where the head and insert were revised.Review of medical records by a consulting clinician did confirm the pain and the elevated cobalt levels.Discoloration of the implants consistent with corrosion was identified in the mar analysis as well.Further information are needed to complete the investigation for determining root cause.If additional information becomes available, this investigation will be reopened.

Event Description

The customer reported that the patient has primary surgery in 2012.The patient presented in the last year with left thigh pain.The customer reported that cobalt and chromium levels are abnormal and that inflammation markers are normal.There were no obvious abnormalities on x-ray.Revision surgery was undertaken on (b)(6) 2016.

• Brand Name: ACCOLADE (127 DEG) SIZE 5.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6090021
• MDR Text Key: 59507880
• Report Number: 0002249697-2016-03545
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 6021-5537
• Device Lot Number: 32408001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention