MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO6 CEMENTLESS RIGHT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	4845-0106
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Insufficient Information (4580)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Prosthetic stem collar breaking.Patient with clear surgical wound after review of right hip prosthesis for collar break.Surgical wound dehiscence after right hip prosthesis revision.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and disassociation involving an abgii stem was reported.The event was confirmed via evaluation of the provided photographs of the device and clinician review of the provided medical records.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted stem with a trunnion that is severely worn and a piece has fractured off.Damage is consistent with the loss of taper lock.The stem also appears to have fractured in overload at the point of wear.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a right total hip arthroplasty on approximately (b)(6) 2008.A revision was carried out approximately 15 years later for head neck disassociation.I can confirm that the head neck disassociation occurred since i was able to see a prerevision x-ray.I can also confirm that a revision was carried out since i was able to review the post revision x-ray.The root cause of head neck disassociation in this case cannot be determined with certainty.Causes of head neck disassociation are multifactorial including surgical technique factors, patient factors including activity level 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 fracture of the stem neck.The reported device was not returned however photographs were provided for review.The photographs show a recently explanted stem with a trunnion that is severely worn and a piece has fractured off.Damage is consistent with the loss of taper lock.The stem also appears to have fractured in overload at the point of wear.The event was further confirmed by clinician review of the provided x-ray images.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
Prosthetic stem collar breaking.Patient with clear surgical wound after review of right hip prosthesis for collar break.Surgical wound dehiscence after right hip prosthesis revision.Update : the surgical wound dehiscence mentioned in the reported details refers to an adverse event that occurred post-revision of stryker devices.The patient was later revised on (b)(6) 2023 (competitor devices) due to infection/wound dehiscence.This pi is for the revision of stryker products which occurred on (b)(6) 2023 due to stem fracture during which competitor devices were implanted.

• Brand Name: ABGII NO6 CEMENTLESS RIGHT 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, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16741074
• Report Number: 0002249697-2023-00386
• Device Sequence Number: 15169131
• Product Code: LPH
• UDI-Device Identifier: 07613327051018
• UDI-Public: 07613327051018
• 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: 2008
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 07/31/2021
• Device Model Number: 4845-0106
• Device Catalogue Number: 4845-0106
• Device Lot Number: G1729225D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2007
• 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: 50 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG