MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/-5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-036

Device Problems Corroded (1131); Degraded (1153); Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding pain and infection involving a metal head was reported.A review by a clinical consultant could not confirm infection.Following material analysis corrosion was confirmed.Method and results: device evaluation and results: visual inspection: a visual inspection was performed as part of the material analysis report.This visual inspection stated that: explantation damage from the revision process was observed on the articulating surface.Adhered material was observed within the taper.Material analysis: explantation damage to v40 lfit head was observed.The dark discoloration observed on the lfit v40 co cr mo head was a mixture of biological material and material transfer from the accolade stem.Evidence of a corrosion process was observed v40 lfit femoral head taper.There was no evidence of manufacturing or material defects on any of the device features examined.Medical records received and evaluation: a review of the medical records by a clinical consultant noted: from the indication for revision surgery, it was evident that infection was suspected which is quite consistent with the limited clinical information and imaging information.Given the available information, a diagnosis of deep joint infection is likely although without explicit proof from the available information.Device history review: all devices in the reported lot 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 and (b)(4) other similar event for the reported sterile lot.Conclusions: a review of the medical records by a clinical consultant concluded: despite negative bacterial cultures, infection was still the most likely cause of failure and patient was treated as if infection was present which is the best approach under the given conditions.Infection is primarily a procedure-related complication generic to every arthroplasty with sometimes additional patient-related risk factors about which there is no explicit information in this case.Infection possibly contributed to partial cup loosening with some radiolucent line formation without gross loosening.No further investigation is required at this time.If additional information becomes available, this investigation will be reopened.

Event Description

The customer reported that the (b)(6), male patient has undergone a revision of a right thr which was implanted on (b)(6) 2013.The patient presented with pain and the surgeon suspected infection and took a decision to revise.During the procedure there was no evidence of infection and the stem was in good condition.There is some damage to the trunnion due to explantation.

• Brand Name: V40 COCR LFIT HEAD 36MM/-5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5704702
• MDR Text Key: 46760448
• Report Number: 0002249697-2016-01848
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2016

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: 01/30/2018
• Device Catalogue Number: 6260-9-036
• Device Lot Number: MLTJ5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2013
• 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): Required Intervention
• Patient Age: 65 YR