MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 23MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-123; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-123
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
Date of Event	03/25/2016
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 an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2016.It is further alleged that he suffered injuries as a result of implantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Patient has not yet scheduled a surgery for explantation of the femoral head at issue.
Additional Manufacturer Narrative
The following devices were also listed in this report: restoration adm x3 ins; cat#: 1236-2-244 ; lot#: 296557.Modular dual mobility insert; cat# 626-00-38d; lot# 54279604.Primary tritanium hemi cluster hole cup 50mm; cat#: 502-03-50d; lot#: 9m8ay5.Acetabular dome hole plug; cat#: 2060-0000-1; lot#: 7k50a7.6.5 cancellous bone screw 35mm; cat#: 2030-6535-1; lot#: 3a8xl6.6.5 cancellous bone screw 35mm; cat#: 2030-6535-1; lot#: km6l5.Mod con dist stem 16 x 195 mm; cat#: 6276-7-116; lot#: caxm823e.Hris flexible osteo 6x67mm; cat#: 6210-0-720; lot#: x15t06a.Hris flexible osteo 8x80mm; cat#: 6210-0-730; lot#: x15w03k.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a restoration modular body was reported.The event for infection was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "the patient apparently had an infection and underwent resection arthroplasty, spacer placement, revision surgery and re or persistent infection.There was a trochanteric fracture and subsequent nonunion.The patient had a history of hiv.No medical records other than the op note were provided for review.No radiographs were provided for review, no laboratory studies were provided for review.Event confirmation: a revision surgery, infection, and trochanteric nonunion may be confirmed.Metallosis or injuries related to thereof cannot be confirmed.Root cause: the root cause of the revisions were an infection.The other event cannot be confirmed thus a root cause cannot be attributed." 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 or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.It was reported that the patient was diagnosed with excessive levels of chromium and cobalt in his blood.A review of the provided medical records by a clinical consultant indicated: "the patient apparently had an infection and underwent resection arthroplasty, spacer placement, revision surgery and re or persistent infection.There was a trochanteric fracture and subsequent nonunion.The patient had a history of hiv.No medical records other than the op note were provided for review.No radiographs were provided for review, no laboratory studies were provided for review.Event confirmation: a revision surgery, infection, and trochanteric nonunion may be confirmed.Metallosis or injuries related to thereof cannot be confirmed.Root cause: the root cause of the revisions were an infection.The other event cannot be confirmed thus a root cause cannot be attributed." all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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 or Problem 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 on (b)(6) 2016.It is further alleged that he suffered injuries as a result of implantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Patient has not yet scheduled a surgery for explantation of the femoral head at issue.Update per med review: on (b)(6) 2016: operative note.Reinfected hip.Washout and debridement and new liner head increased to +6mm.Pt with hiv.Prior infection, spacer, reimplantation.Developed infection with oozing 6 months postop.Wanted to try washout and suppression.Trochanter found to have nonunion.Has short leg new liner and head placed.

• Brand Name: 23MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-123
• Common Device Name: 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-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 8473406
• Report Number: 0002249697-2019-01503
• Device Sequence Number: 1612150
• Product Code: LPH
• UDI-Device Identifier: 04546540641151
• UDI-Public: 04546540641151
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 6276-1-123
• Device Lot Number: 53688406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2015
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male