MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO7 CEMENTLESS LEFT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	4845-0207
Medical Device Problem Codes	Corroded (1131); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Necrosis (1971); Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional 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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Catalog numbers and lot codes of other devices listed in this report: cat # mac-9988-4854, lot # fm061643, description: std mitch trh cp sz 48/54, oem, manufacturer: depuy.Cat # mmh-9988-1448, lot # fm072658, description: mitch trh md hd sz 48+4 oem, manufacturer: depuy.
Event or Problem Description
Our agent reported: "an abg stem implant with mitch, implanted over 11 years ago, has been revised.The large head consumed the morse taper of the stem causing dislocation of the head and necessitating the removal of the stem and reimplantation of a modular restoration with mdm".
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and corrosion/metallosis involving an abgii stem was reported.The event was confirmed via evaluation of the returned device as well as clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection: visual inspection indicated damage observed on the trunnion and neck of the hip stem is consistent with loss of the taper lock.Bone ingrowth visible on the body of the stem.Clinician review: a review of the provided medical records by a clinical consultant indicated the following: "this patient sustained a head neck disassociation which deformed the trunnion of the femoral stem necessitating revision surgery.The pathological report indicated some blackish pigmentation which could indicate the presence of corrosion.I can confirm that this event occurred since there is a pathology report indicating that the stem was removed and a pathological diagnosis was obtained.The causes of had neck disassociation with corrosion 12 years following surgery or multifactorial.I cannot confirm the root cause of this event.Causes include factors related to surgical technique, patient activity levels and bmi, and implant factors." -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 referenced.Conclusions: it was reported that the patient was revised due to disassociation of the stem from the head.Visual inspection indicated damage observed on the trunnion and neck of the hip stem is consistent with loss of the taper lock.Bone ingrowth visible on the body of the stem.A review of the provided medical records by a clinical consultant indicated the following: "this patient sustained a head neck disassociation which deformed the trunnion of the femoral stem necessitating revision surgery.The pathological report indicated some blackish pigmentation which could indicate the presence of corrosion.I can confirm that this event occurred since there is a pathology report indicating that the stem was removed and a pathological diagnosis was obtained.The causes of had neck disassociation with corrosion 12 years following surgery or multifactorial.I cannot confirm the root cause of this event.Causes include factors related to surgical technique, patient activity levels and bmi, and implant factors." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Our agent reported: "an abg stem implant with mitch, implanted over 11 years ago, has been revised.The large head consumed the morse taper of the stem causing dislocation of the head and necessitating the removal of the stem and reimplantation of a modular restoration with mdm".

• Brand Name: ABGII NO7 CEMENTLESS LEFT V40
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16441456
• Report Number: 0002249697-2023-00189
• Device Sequence Number: 5860016
• Product Code: LPH
• UDI-Device Identifier: 07613327051063
• UDI-Public: 07613327051063
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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: 10/31/2011
• Device Model Number: 4845-0207
• Device Catalogue Number: 4845-0207
• Device Lot Number: G1465625A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/26/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2006
• 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 Sex: Unknown