MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO5 CEMENTLESS LEFT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	4845-0205
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Dr.Report: "i would like to inform you of the wear (breakage) of the femoral stem neck of the abg prosthesis.Code: how / ost 4845-0205 abg ii femoral stem left.The patient had to undergo a prosthetic replacement surgery - on (b)(6) 2020".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a abgii stem was reported.The event was confirmed through visual evaluation of the provided photograph.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show an abgii stem.Damage/crack/fracture is visible on the trunnion neck of the stem.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all 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: the reported device was not returned however photographs were provided for review.The photographs show an abgii stem.Damage/crack/fracture is visible on the trunnion neck of the stem.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, progress notes, x-rays and return of the device 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
Dr.Report: "i would like to inform you of the wear (breakage) of the femoral stem neck of the abg prosthesis.Code: how / ost 4845-0205 abg ii femoral stem left.The patient had to undergo a prosthetic replacement surgery - on (b)(6) 2020.".

• Brand Name: ABGII NO5 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
• MDR Report Key: 10883613
• Report Number: 0002249697-2020-02524
• Device Sequence Number: 19585046
• Product Code: LPH
• UDI-Device Identifier: 07613327051032
• UDI-Public: 07613327051032
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 06/30/2012
• Device Model Number: 4845-0205
• Device Catalogue Number: 4845-0205
• Device Lot Number: G1771910A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention