MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI CLUSTER HOLE CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-58F
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Necrosis (1971); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	07/28/2017
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 his right hip on or about (b)(6) 2012 and was revised on (b)(6) 2017.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.The acetabular component was grossly loose, rotated and demonstrated no bony ingrowth.The acetabular screw had fractured approximately 5 mm into subchondral bone.The patient's tissue below that fascial layer showed an extremely abundant aggressive pseudocapsule formation with necrosis of the tissue consistent with an aggressive tissue reaction.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident 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: "conclusion/assessment: very little medical information was provided.There is no preop workup for the revision surgery, there were no metal levels, there is no imaging.The clinical history was limited to an operative note and the pi report.Patient underwent revision surgery for catastrophic failure of his acetabulum.They are attributing the failure to trunnionosis.Again, no photographs or other data are presented to support the findings.The patient did undergo revision surgery for catastrophic failure of an acetabular component with gross loosening and acetabular bone loss.The patient had a v40 head in place.It was cobalt chrome.Event confirmation: a revision hip surgery can be confirmed.Metallosis was noted at the trunnion.Increased metal levels cannot be confirmed.Injuries from the implantation/expectations of the components cannot be confirmed.Device recall cannot be confirmed.Root cause: the root cause of the revision surgery appears to be catastrophic failure/loosening of the acetabular component.A root cause for reported metallosis, increased metal levels, injuries, or device recall cannot be ascertained as they cannot be confirmed." -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 elevated metal ion levels.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: very little medical information was provided.There is no preop workup for the revision surgery, there were no metal levels, there is no imaging.The clinical history was limited to an operative note and the pi report.Patient underwent revision surgery for catastrophic failure of his acetabulum.They are attributing the failure to trunnionosis.Again, no photographs or other data are presented to support the findings.The patient did undergo revision surgery for catastrophic failure of an acetabular component with gross loosening and acetabular bone loss.The patient had a v40 head in place.It was cobalt chrome.Event confirmation: a revision hip surgery can be confirmed.Metallosis was noted at the trunnion.Increased metal levels cannot be confirmed.Injuries from the implantation/expectations of the components cannot be confirmed.Device recall cannot be confirmed.Root cause: the root cause of the revision surgery appears to be catastrophic failure/loosening of the acetabular component.A root cause for reported metallosis, increased metal levels, injuries, or device recall cannot be ascertained as they cannot be confirmed." 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 58MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19823713
• Report Number: 0002249697-2024-01024
• Device Sequence Number: 18295918
• Product Code: LPH
• UDI-Device Identifier: 07613327040159
• UDI-Public: 07613327040159
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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 Catalogue Number: 502-03-58F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male