MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +8 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-328
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414); Metal Related Pathology (4530)
Date of Event	03/07/2011
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem 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) 2008 and was revised on (b)(6) 2011.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.
Event or Problem 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) 2008 and was revised on (b)(6) 2011.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Additional information as per medical records received oct-16-2023: "the hip was noted to be dislocated.The femoral head was removed.This was followed by removal of a dissociated constrained liner.Constrained liner was dissociated from the head as well as the cup.".
Additional Manufacturer Narrative
Reported event: 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 descriptions from the product inquiry summaries state: 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) 2008 and was revised on (b)(6) 2011.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Additional information as per medical records received (b)(6) 2023: "the hip was noted to be dislocated.The femoral head was removed.This was followed by removal of a dissociated constrained liner.Constrained liner was dissociated from the head as well as the cup." the operative report dated brief operative report and sticker sheet from (b)(6) 11denote that in the revision tha performed on the acetabular liner was exchanged for a constrained liner.The operative report from a revision tha performed om (b)(6) 2017 describes that the constrained liner had dissociated from the acetabular shell, the head remained within the constrained liner.The constrained liner was revised to an adm liner that was cemented in to a well fixed protrusio cup and the head exchanged.The documentation provided confirms that a primary tha was revised for instability on (b)(6) 2011.A second revision tha surgery was performed on (b)(6) 2017 for dissociation of a constrained liner.No documentation was available to confirm excess levels of cobalt and chromium in the blood.The root cause of these tha failures cannot be determined from the limited documentation provided.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.Conclussion: it was reported that the patient was revised due to excessive levels of chromium and cobalt in his blood, as per medical records received "constrained liner was dissociated from the head as well as the cup." a review of the provided medical records by a clinical consultant indicated: the event descriptions from the product inquiry summaries state: 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) 2008 and was revised on (b)(6) 2011.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Additional information as per medical records received (b)(6) 2023: "the hip was noted to be dislocated.The femoral head was removed.This was followed by removal of a dissociated constrained liner.Constrained liner was dissociated from the head as well as the cup." the operative report dated brief operative report and sticker sheet from (b)(6) 2011 denote that in the revision tha performed on the acetabular liner was exchanged for a constrained liner.The operative report from a revision tha performed om (b)(6) 2017 describes that the constrained liner had dissociated from the acetabular shell, the head remained within the constrained liner.The constrained liner was revised to an adm liner that was cemented in to a well fixed protrusio cup and the head exchanged.The documentation provided confirms that a primary tha was revised for instability on (b)(6) 2011.A second revision tha surgery was performed on (b)(6) 2017 for dissociation of a constrained liner.No documentation was available to confirm excess levels of cobalt and chromium in the blood.The root cause of these tha failures cannot be determined from the limited documentation provided.Should additional information become available i would be happy to further this assessment.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.

• Brand Name: 28MM +8 V40 TAPER VIT HEAD
• Common Device Name: 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 9075197
• Report Number: 0002249697-2019-03222
• Device Sequence Number: 2503184
• Product Code: JDI
• UDI-Device Identifier: 07613327012927
• UDI-Public: 07613327012927
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 6260-5-328
• Device Lot Number: 26231402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male