MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 36MM, +5MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6565-0-236

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problems Edema (1820); Inflammation (1932); Injury (2348)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The surgeon reported that the patient's right hip was revised as a result of trunnionosis.The surgeon reported that a pseudotumor was visible on scan images.

Manufacturer Narrative

An event regarding altr involving an exeter stem was reported.Wear was confirmed through a mar and a review by a clinician.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 26 jan 2018.The parts were examined with the aid of a stereo microscope at magnifications up to 50x.Metal transfer marking were observed on the head, consistent with the explantation process.Wear scars were also observed on the head, consistent with wear due to contact against the insert.A continuous metal transfer ring was observed at the proximal end of the taper, indicating proper seating between the stem trunnion and head taper.Adhered debris was observed on the taper, likely from the stem.Wear scars were not observed on the taper of the head.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed because the event is related to in-vivo performance and therefore functionality could not be duplicated.Material analysis: a material analysis has been performed.The report concluded: adhered debris was observed on the stem and head taper.Wears scars were observed on the articulating surfaces of the head and insert, consistent with contact against each other.Explantation damages were observed on the returned devices.Eds showed the stem was consistent with astm f1586 alloy and the debris was consistent with a corrosion product, biological material and the stem base alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: cup malposition in near absent anteversion has caused impingement between stem neck and ceramic sleeve rim with osteolysis behind the cup, taper corrosion, wear scar on the femoral head and pseudo tumor with armd and metallosis as secondary adverse effects requiring revision.A specific lot for the reported complaint is unknown.A batch lot was provided which is associated with the following lots: 11735501; 11763601; 11790001; 11864601; 13118901; 13118902 and 14633301 device 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.Conclusion: the investigation concluded that cup malposition in near absent anteversion has caused impingement between stem neck and ceramic sleeve rim with osteolysis behind the cup, taper corrosion, wear scar on the femoral head and pseudo tumor with armd and metallosis as secondary adverse effects requiring revision.

Event Description

The surgeon reported that the patient's right hip was revised as a result of trunnionosis.The surgeon reported that a pseudotumor was visible on scan images.Update: a review by a clinical consultant has noted "cup malposition in near absent anteversion has caused impingement between stem neck and ceramic sleeve rim with osteolysis behind the cup, taper corrosion".

• Brand Name: ALUMINA V40-FEMORAL HEAD 36MM, +5MM NK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7158897
• MDR Text Key: 96206268
• Report Number: 0002249697-2018-00025
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K023901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6565-0-236
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 69