MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 03/07/2011

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation involving an unknown shell 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 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." 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.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: 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 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." 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.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, pre- and post-operative x-rays and the revision operative report 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) 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.".

• Brand Name: UNKNOWN_SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18095305
• MDR Text Key: 327667838
• Report Number: 0002249697-2023-01360
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2023

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 Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Sex: Male