MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6021-0435

Device Problems Corroded (1131); Material Disintegration (1177); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that the patient's left hip was revised due to dissociation of the femoral head.Intra-operatively, extreme trunnion wear and an extreme amount of black tissue were noted.The patient's stem, head and poly liner were revised to a securfit stem, ceramic head, and another poly liner.Rep confirmed that there are no allegations against the revised liner, can provided pictures, and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event of disassociation and metallosis involving an accolade stem was reported.The event of disassociation was confirmed through clinical comment of the provided x-ray.Metallosis and wear were not confirmed.Method & results:  -device evaluation and results: not performed as product was not returned.  -clinician review: a review of the provided medical records by a clinical consultant stated the following comment: pi which represents a male patient whose date of implantation is listed as (b)(6) 2012 and explantation (b)(6) 2020.The event description states: ".Left hip was revised due to disassociation of the femoral head.Extreme trunnion wear and extreme amount of black tissue was noted." undated, unlabeled x-ray: ap pelvis demonstrating bilateral uncemented tha with the right side nominal and the left side with the stem trunnion disassociated and dislocated from the modular femoral head which remains in the acetabular component.No clinical or pmh, no patient demographics, no operative reports, no surgical pathology reports, no examination of explanted components and no dated serial -rays.Based upon the single x-ray provided, complete confirmation of the event description or preparation of a medical report is not possible for this case.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided x-ray by a consultant clinician indicated: bilateral uncemented tha with the right side nominal and the left side with the stem trunnion disassociated and dislocated from the modular femoral head which remains in the acetabular component.The exact cause of the event cannot be confirmed as insufficient information was provided further information such as clinical or past medical history, patient demographics, operative reports, surgical pathology reports, examination of explanted components and dated serial -rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that the patient's left hip was revised due to dissociation of the femoral head.Intra-operatively, extreme trunnion wear and an extreme amount of black tissue were noted.The patient's stem, head and poly liner were revised to a securfit stem, ceramic head, and another poly liner.Rep confirmed that there are no allegations against the revised liner, can provided pictures, and confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Added device lot number reported event: an event of disassociation and metallosis involving an accolade stem was reported.The event of disassociation was confirmed through clinical comment of the provided x-ray.Metallosis and wear were not confirmed.Method & results:  -device evaluation and results: not performed as product was not returned.  -clinician review: a review of the provided medical records by a clinical consultant stated the following comment: pi which represents a male patient, dob (b)(6) 1957 whose date of implantation is listed as (b)(6) 2012 and explantation (b)(6)2020.The event description states: ".Left hip was revised due to disassociation of the femoral head.Extreme trunnion wear and extreme amount of black tissue was noted." undated, unlabeled x-ray: ap pelvis demonstrating bilateral uncemented tha with the right side nominal and the left side with the stem trunnion disassociated and dislocated from the modular femoral head which remains in the acetabular component.No clinical or pmh, no patient demographics, no operative reports, no surgical pathology reports, no examination of explanted components and no dated serial -rays.Based upon the single x-ray provided, complete confirmation of the event description or preparation of a medical report is not possible for this case.-device history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.  -complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided x-ray by a consultant clinician indicated: bilateral uncemented tha with the right side nominal and the left side with the stem trunnion disassociated and dislocated from the modular femoral head which remains in the acetabular component.The exact cause of the event cannot be confirmed as insufficient information was provided further information such as clinical or past medical history, patient demographics, operative reports, surgical pathology reports, examination of explanted components and dated serial -rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not available.

Event Description

It was reported that the patient's left hip was revised due to dissociation of the femoral head.Intra-operatively, extreme trunnion wear and an extreme amount of black tissue were noted.The patient's stem, head and poly liner were revised to a securfit stem, ceramic head, and another poly liner.Rep confirmed that there are no allegations against the revised liner, can provided pictures, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10501147
• MDR Text Key: 205882708
• Report Number: 0002249697-2020-01804
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510693
• UDI-Public: 04546540510693
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2021

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: 10/31/2018
• Device Model Number: 6021-0435
• Device Catalogue Number: 6021-0435
• Device Lot Number: 38166006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 05/21/2021
• Supplement Dates FDA Received: 11/08/2020; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR