MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-228

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414); Metal Related Pathology (4530)

Event Date 05/06/2013

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with and lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2013 and has not yet scheduled a surgery for explantation of the femoral head.It is further alleged that he suffered injuries as a result of implantation of the devices at issue and excessive levels of cobalt and chromium in his blood.

Manufacturer Narrative

An event regarding abnormal ion level involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: the event description from the product inquiry summary states: it was reported through the filing of a lawsuit that allegedly the patient was implanted with and lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2013 and has not yet scheduled a surgery for explantation of the femoral head.It is further alleged that he suffered injuries as a result of implantation of the devices at issue, device recall and excessive levels of cobalt and chromium in his blood.Implant records from (b)(6) 2013 verify that a v40 cocr lfit femoral head was implanted.No documentation was provided that would support injuries related to its implantation.Should additional information become available i would be happy to further this assessment.Product history review: review of the device history records indicate 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: a review of the provided medical records by a clinical consultant indicated: 'implant records from (b)(6) 2013 verify that a v40 cocr lfit femoral head was implanted.No documentation was provided that would support injuries related to its implantation.' the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, and the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with and lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2013 and has not yet scheduled a surgery for explantation of the femoral head.It is further alleged that he suffered injuries as a result of implantation of the devices at issue and excessive levels of cobalt and chromium in his blood.

• Brand Name: 28MM +4 LFIT V40 HEAD
• 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-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8204425
• MDR Text Key: 131696365
• Report Number: 0002249697-2018-04175
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327013061
• UDI-Public: 07613327013061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

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: 11/30/2014
• Device Catalogue Number: 6260-9-228
• Device Lot Number: 31744203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2009
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Male