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

Catalog Number 6020-0435

Device Problems Corroded (1131); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

End user has reported that a severe accolade taper corrosion had happened to the patient other hip's accolade stem about 9 months ago for the opposite side of the hip.

Manufacturer Narrative

An event regarding corrosion involving an accolade stem was reported.The event was confirmed through review of the medical records provided.Disassociation of the metal head from stem trunnion and osteolysis were also confirmed based on the medical review.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinician indicated the following comment: the x-rays confirm the event with catastrophic trunnion failure with a lot of metallic debris in and around the joint on both sides.Also on the right side did a catastrophic trunnion failure occur, reportedly some 9-months earlier, also with loss of taper lock functionality and disassociation between femoral head and stem trunnion that also on this side showed major metal substance loss on x-ray with the typical ¿pencil-shape¿ deformity of the trunnion stump.Major osteolysis was present on the right side with absorption of major part of the greater trochanter requiring cerclage wires for stabilisation after exchange of the stem for a rm construct.With regard to the potential causes for the problem, there are hardly any clues.Frequently component malposition plays a role but both cups show excellent component position with regard to the acetabulum for both inclination and anteversion while the cup is perfectly flush with the surrounding acetabular bone.Also on the stem side no obvious problems on both sides although stem anteversion cannot be measured on plain x-rays, would require a ct-scan.The only potential relevant factor might have been the use of a 44-mm large femoral head although even for this, the scientific evidence is minimal.Larger heads have higher angular speed for the same movement relative to the polyethylene than smaller heads, thus show higher bearing friction which could increase the level of micromotion in the stem trunnion.But as discussed before, the literature is not (yet) supporting this factor although there are some articles that do show an increase of trunnion corrosion problems with longer heads by increase in lever arm across the trunnion.Theoretically, similar arguments might play with larger heads but with current information and current level of scientific information from the literature, both pi cases cannot be solved due to lack of information.Product history review: 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 reported lot.Conclusions: the reported event was confirmed through review of the returned medical records.While the clinician has indicated that the root cause of the event could not be determined, the subject device has been identified to be mated with a metal head within scope of nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope ofnc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

Event Description

End user has reported that a severe accolade taper corrosion had happened to the patient other hip's accolade stem about 9 months ago for the opposite side of the hip.Update 19 march 2019: this pi is for the patients right hip.Update 10 june 2019: comments provided by consulting clinician have indicated: also on the right side did a catastrophic trunnion failure occur, reportedly some 9-months earlier, also with loss of taper lock functionality and disassociation between femoral head and stem trunnion that also on this side showed major metal substance loss on x-ray with the typical ¿pencil-shape¿ deformity of the trunnion stump.Major osteolysis was present on the right side with absorption of major part of the greater trochanter requiring cerclage wires for stabilisation after exchange of the stem for a rm (restoration modular) construct.

• Brand Name: ACCOLADE 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: 8239816
• MDR Text Key: 132797305
• Report Number: 0002249697-2019-00152
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 6020-0435
• Device Lot Number: 26485905
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention