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

Model Number 6260-9-236

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530)

Event Date 05/31/2022

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Device not returned.

Event Description

As reported, patient presented with raised cobolt and chromium levels.Lfit head removed from accolade ii stem and replaced during revision surgery.

Manufacturer Narrative

Reported event: an event regarding corrosion and abnormal ion level involving a metal head was reported.The corrosion event was confirmed through evaluation of the returned device.Abnormal ion level was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the metal head has black discoloration on the inner tapered surface.Some nicks are visible on the distal surface of the head; this damage is consistent with explantation.Material analysis: a material analysis was performed and concluded the following: "review of v40 cocr lfit head 36mm/+5, catalogue # 6260-9-236, lot code mkelw8 confirmed the presence of black discolouration.Characterisation using energy dispersive spectroscopy confirmed oxidation of the component in the discoloured regions indicating corrosion.No manufacturing related defects were observed on the examined areas of the component.".Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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.Conclusions: it was reported that the patient was revised due to elevated cobalt and chromium levels.Visual inspection of the returned device indicated that the metal head has black discoloration on the inner tapered surface.Some nicks are visible on the distal surface of the head; this damage is consistent with explantation.A material analysis was performed and concluded the following: "review of v40 cocr lfit head 36mm/+5, catalogue # 6260-9-236, lot code mkelw8 confirmed the presence of black discolouration.Characterisation using energy dispersive spectroscopy confirmed oxidation of the component in the discoloured regions indicating corrosion.No manufacturing related defects were observed on the examined areas of the component." further information such as pathology reports, the revision operative report, patient history, and follow-up notes are needed to confirm the elevated ion levels and to investigate root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported, patient presented with raised cobolt and chromium levels.Lfit head removed from accolade ii stem and replaced during revision surgery.

• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14838307
• MDR Text Key: 295068565
• Report Number: 0002249697-2022-00926
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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: 05/01/2016
• Device Model Number: 6260-9-236
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MKELW8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2011
• 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): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male