MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI CLUSTER HOLE CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-48C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	12/18/2014
Type of Reportable Event	Serious Injury
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 her right hip on or about (b)(6) 2011 and was revised on (b)(6) 2014.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of cobalt and chromium in her blood.Additional information per medical records received: "exposed some bursal tissue and metallic fluid on the superolateral aspect of the greater trochanter, tracked down into the joint space.I noticed a large defect in the superior lateral aspect of the base of the neck of the implant, indicating impingement." update per medical review: the cup was noted and the patient was diagnosed with a loose acetabular component.Findings at surgery included right hip extensive metallosis within the joint space the femoral component was well fixed the acetabular component was grossly loose the mdm metal insert impinged against the stem of the femur and had worn away approximately 20 to 25% of the base of the neck of the implant on the it's posterior superior aspect.
Additional Manufacturer Narrative
An event regarding abnormal ion level & altr involving a was reported.The event was confirmed via medical review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinical review - a review of the provided medical records by a clinical consultant indicated: "summary: this product inquiry concerns a female patient was 54 years of age at the time of the event.She underwent a primary total hip arthroplasty on (b)(6) 2011.A cementless implant was utilized with an accolade tmzf stem and a titanium hemispherical cup.The patient did initially well but then developed groin pain.The patient underwent revision surgery on (b)(6) 2014 where some metallosis and rather severe impingement on the posterior aspect of the femoral neck with the mdm metal liner was found.Confirmation of event: i can confirm that the patient did have a primary total hip arthroplasty on (b)(6), 2011 since i was able to review the implant sheet with stryker implants.I can also confirm that the patient underwent revision surgery on (b)(6) 2014 since i was able to review the operation report.Root cause analysis: i can confirm that the patient did have a primary total hip arthroplasty on (b)(6) 2011 since i was able to review the implant sheet with stryker implants.I can also confirm that the patient underwent revision surgery on (b)(6) 2014 since i was able to review the operation report.In this case i believe the root cause of this event can be determined with relative certainty.The surgeon stated that there was rather severe impingement with loss of volume of the posterior aspect of the implanted femoral head on the implanted acetabular component.Findings, it can be summarized that infringement occurred most likely in extension and this would be due to either increased anteversion in the cup or perhaps anteversion of the femoral stem.Given the mechanical impinge, i would not assign any causality plant itself.I believe the impingement and subsequent need for revision was caused by the positioning of the components which allowed impingement.Having said that if components somehow moved since the initial operation, then it might not be positioning." -product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to elevated ion level.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient did have a primary total hip arthroplasty on (b)(6) 2011 since i was able to review the implant sheet with stryker implants.I can also confirm that the patient underwent revision surgery on (b)(6) 2014 since i was able to review the operation report.In this case i believe the root cause of this event can be determined with relative certainty.The surgeon stated that there was rather severe impingement with loss of volume of the posterior aspect of the implanted femoral head on the implanted acetabular component.Findings, it can be summarized that infringement occurred most likely in extension and this would be due to either increased anteversion in the cup or perhaps anteversion of the femoral stem.Given the mechanical impinge, i would not assign any causality plant itself.I believe the impingement and subsequent need for revision was caused by the positioning of the components which allowed impingement.Having said that if components somehow moved since the initial operation, then it might not be positioning." 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: PRIMARY TRIT HEMI CLUSTER HOLE CUP 48MM
• 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 NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20181833
• Report Number: 0002249697-2024-01235
• Device Sequence Number: 8261437
• Product Code: LPH
• UDI-Device Identifier: 07613327040111
• UDI-Public: 07613327040111
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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: 03/31/2016
• Device Catalogue Number: 502-03-48C
• Device Lot Number: MKELJ8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2011
• 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: 52 YR
• Patient Sex: Female