MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; IMPLANT

Catalog Number 6021-0335

Device Problems Material Separation (1562); Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 05/07/2015

Event Type  Injury  

Event Description

The patient reported to the surgeon secondary to increased left hip pain 8 years status post ltha.X rays revealed disassociation of the lfit head from the accolade stem along with deformation of the stem's trunion.The patient was subsequently scheduled for revision surgery on (b)(6) 2015.The surgeon removed the accolade tmzf stem, lfit head, and x3 liner.He implanted a securfit advanced stem, a new x3 liner and a 36mm bilox delta head.He elected to leave the trident hemispherical shell originally implanted.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding disassociation and altr (metallosis) involving an accolade stem was reported.The event was confirmed.Method and results: device evaluation and results: a visual inspection was completed as part of the material analysis report dated (b)(6) 2015: the material damage to the trunnion is consistent with the stem disassociating from the head, allowing the trunnion to come in contact with the distal rim of the insert.The material analysis report concluded that the damaged observed on the insert and trunnion resulted from the disassociation of the stem from the head, allowing the trunnion to make contact with the insert.It was not possible to determine why the stem to head taper came loose.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review of the provided records and event description was performed by a clinical consultant.The clinical consultant indicated 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 as final effect with dissociation of the femoral head from the taper.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: complaint history review indicated there have been no other similar events for the reported lot.Conclusions: a review of the event by a clinical consultant concluded that 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 as final effect with dissociation of the femoral head from the taper.No further investigation is possible at this time.If further information becomes available , this investigation will be re-opened.

Event Description

The patient reported to the surgeon secondary to increased left hip pain 8 years status post ltha.X rays revealed disassociation of the lfit head from the accolade stem along with deformation of the stem's trunion.The patient was subsequently scheduled for revision surgery on (b)(6) 2015.The surgeon removed the accolade tmzf stem, lfit head, and x3 liner.He implanted a securfit advanced stem, a new x3 liner and a 36mm bilox delta head.He elected to leave the trident hemispherical shell originally implanted.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4813172
• MDR Text Key: 16462229
• Report Number: 0002249697-2015-01783
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

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: 04/30/2011
• Device Catalogue Number: 6021-0335
• Device Lot Number: 17797301
• Other Device ID Number: STER. LOT 0604IIRZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2006
• 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: 83 YR
• Patient Weight: 93