MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 28MM, +4MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6565-0-228

Device Problems Break (1069); Fracture (1260); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported directly: ¿in (b)(6) 2014, i had a hip replacement at (b)(6) done by consultant surgeon.This was deemed a success until three weeks or so ago when i felt severe pain in the hip region and contacted the surgeon immediately.X-rays caused some concern as there seemed to be a failure in the head of the replacement, and another operation has since been carried out to rectify the problems.

Manufacturer Narrative

An event regarding crack/fracture involving a ceramic head was reported.The event was confirmed through a mar and review of medical records by a clinical consultant.Method & results: device evaluation and results: {.}visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 19 jan 2018.Images of the device are included in the mar.As per mar {.}.The devices were examined with the aid of a stereo microscope at magnifications up to 50x.{.}.The fragments were examined for evidence of a continuous metal transfer ring on the taper surface which indicates proper seating of the head on the trunnion.A continuous metal transfer ring was not observed on the taper surface.The fragments were observed to have post fracture chipping and abrasion which obscured the fracture surface and prevented further analysis.{.} dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed due to a material integrity issue as there is evidence from the visual inspection that the device is damaged.Material analysis: the mar concluded {.} the fracture origin of the ceramic head could not be determined since the fragments of the ceramic head had post fracture chipping and abrasion which obscured the fracture surface.Based on the given information, no identifiable material discrepancies were observed on the surfaces examined.{.}{.} medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: {.}procedure-related factors: cup malposition in retroversion and medialization.Patient-related factors posterior acetabular wall bone defect after acetabular fracture.Device-related factors: none.Diagnosis: cup malposition in retroversion and medialization, probably triggered by a posterior acetabular wall bone defect after acetabular fracture has contributed to an overload condition in the arthroplasty resulting in a ceramic femoral head fracture after 3½-years requiring revision.{.} 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 the ceramic head crack/fracture was caused by {.}cup malposition in retroversion and medialization, probably triggered by a posterior acetabular wall bone defect after acetabular fracture has contributed to an overload condition in the arthroplasty resulting in a ceramic femoral head fracture after 3½-years requiring revision.{.}.

Event Description

The patient reported directly: ¿in spring 2014, i had a hip replacement at (b)(6) done by consultant surgeon.This was deemed a success until three weeks or so ago when i felt severe pain in the hip region and contacted the surgeon immediately.X-rays caused some concern as there seemed to be a failure in the head of the replacement, and another operation has since been carried out to rectify the problems.

• Brand Name: ALUMINA V40-FEMORAL HEAD 28MM, +4MM 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7104395
• MDR Text Key: 94393690
• Report Number: 0002249697-2017-03532
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K023901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

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: 01/06/2016
• Device Catalogue Number: 6565-0-228
• Device Lot Number: 35772401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2011
• 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