MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6020-0537

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 05/14/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Revision hip arthroplasty removal and exchange.Disassociation of stem from femoral head.Implants sent to pathology per dr.(b)(6).Products are available for return as well as x-rays.No further information due to hospital policy.

Manufacturer Narrative

Corrected data: device not returned.An event regarding disassociation involving an accolade stem was reported.The event was confirmed through the medical review.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.Images of the device were however provided.Severe trunnion damage was noted.-medical records received and evaluation: a medical review was performed and concluded: "cup malposition in absent anteversion has contributed to overload in the bearing section of the arthroplasty causing excessive micromotion between stem taper and femoral head leading to catastrophic taper damage with dissociation of the femoral head from the taper requiring revision." -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 no other similar events for the reported lot.Conclusions: a medical review was performed and concluded the disassociation event was caused by cup malposition.The medical review indicated that there were no device related factors present.No further investigation is required at this time.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Revision hip arthroplasty removal and exchange.Dissasociation of stem from femoral head.Implants sent to pathology per dr.(b)(6).Products are available for return as well as x-rays.No further information due to hospital policy.

Manufacturer Narrative

Additional patient information was provided.

Event Description

Revision hip arthroplasty removal and exchange.Dissasociation of stem from femoral head.Implants sent to pathology per dr.(b)(6).Products are available for return as well as x-rays.No further information due to hospital policy.Per medical review, the root cause of the patients' revision was cup malposition.

• Brand Name: ACCOLADE TMZF HIP STEM #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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5710472
• MDR Text Key: 47091195
• Report Number: 0002249697-2016-01905
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/01/2017

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: 04/30/2012
• Device Catalogue Number: 6020-0537
• Device Lot Number: 22188301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided; 07/05/2017
• Supplement Dates FDA Received: 08/12/2016; 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 93