MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HIPSTAR V40 STEM N Ø5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number 7850-1-005

Device Problems Corroded (1131); Loss of Osseointegration (2408); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2007 and was revised on (b)(6) 2020.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, device recall and excessive levels of chromium and cobalt in his blood.

Manufacturer Narrative

Reported event an event regarding disassociation, loosening, osteolysis and abnormal ion level involving a hipstar stem 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 information by a clinical consultant indicated: this inquiry reports the failure of a right total hip arthroplasty approximately 13 years after implantation due to femoral loosening, osteolysis, and head disassociation.I can confirm this event took place since i was able to read the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of femoral loosening or multifactorial including surgical technique factors, patient activity factors and patient¿s height and weight.Causes of osteolysis are multifactorial including poly wear and other types of particle synovitis.Causes of head disassociation are multifactorial including trunnion failure, and corrosion.In this case i cannot confirm corrosion since there is no metallurgical analysis.-product history review: could not be performed as lot number was invalid.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the reported unknown stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.No further investigation for this event is required at this time.If 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 an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2007 and was revised on (b)(6) 2020.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, device recall and excessive levels of chromium and cobalt in his blood.Update on 03-mar-2022 per clinician review: an operative note by dr.Dated (b)(6) 2020 is provided.The preoperative diagnosis was ¿mechanical loosening of prosthetic hip¿ and the postop diagnosis was the same.The operation performed was a revision right total hip arthroplasty.The surgeon used a cementless 70 mm shell, a polyethylene with a 28 mm inner diameter, a wagner sl femoral stem was utilized, demineralized bone putty, and a 28 mm femoral head was utilized.Femoral component was grossly loose.There was no evidence of infection.The surgeon describes a huge amount of osteolysis with "amorphous sludge type of whitish gray material".He states that the femoral head was disassociated from the femoral stem and there was a large amount of corrosive black typical material on both the male trunnion as well as the female portion of the femoral head." per operative report: the explant osteotome was used to remove the well-fixed acetabular component.There were no significant defects behind the acetabular shell.

• Brand Name: HIPSTAR V40 STEM N Ø5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12860273
• MDR Text Key: 281137513
• Report Number: 0002249697-2021-01949
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051223
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7850-1-005
• Device Lot Number: INVALID
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male