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	Fall (1848); Pain (1994)
Date of Event	09/03/2021
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.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.Device not returned.
Event or Problem Description
It has been reported that: "(b)(6) patient with a left total hip prosthesis in 2008.Rupture of the left total hip prosthesis at the neck of the stem, following an impact with a door and a fall with landing on the left hip.Pain in the left hip with functional impotence mig.Action taken: orthopaedic surgery to fit new prosthetic material.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an abgii stem was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the stem is fractured at the neck.Scratches are present on the surface of the neck.The ceramic head remains attached to the trunnion.Material analysis: a material analysis was performed and concluded the following: "the stem fractured due to fatigue mode failure.A fracture initiated at a lateral edge and propagated medially until the stress on the remaining material fractured in overload.No material non-conformances were found on any of the four devices, nor were any manufacturing defects seen on any surfaces inspected here." -clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry reports the failure of a left total hip arthroplasty about 3 ½ years postop due to fracture of the femoral stem at the base of the trunnion.I can confirm that this event took place since i was able to review the operation reports, radiographs and photos of the explanted fractured stem and revised acetabular component.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of stem and trunnion fracture are multifactorial including surgical technique, impingement, patient activity factors, and implant factors." -product history review: review of the device history records indicate the 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 abgii stem following a fall.Visual inspection of the returned device confirmed stem fracture at the neck.A material analysis was performed and concluded the following: "the stem fractured due to fatigue mode failure.A fracture initiated at a lateral edge and propagated medially until the stress on the remaining material fractured in overload.No material non-conformances were found on any of the four devices, nor were any manufacturing defects seen on any surfaces inspected here." a review of the provided op reports and x-ray images by a clinical consultant also confirmed the event.The root cause of the event could not be determined from the information provided; however, it is likely that the reported trauma event contributed to the device failure.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
It has been reported that: "64 year old patient with a left total hip prosthesis in 2008.Rupture of the left total hip prosthesis at the neck of the stem, following an impact with a door and a fall with landing on the left hip.Pain in the left hip with functional impotence mig.- action taken: orthopaedic surgery to fit new prosthetic material.".

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12569339
• Report Number: 0002249697-2021-01665
• Device Sequence Number: 4054102
• Product Code: LPH
• UDI-Device Identifier: 07613327051032
• UDI-Public: 07613327051032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2022

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: 03/31/2013
• Device Model Number: 4845-0205
• Device Catalogue Number: 4845-0205
• Device Lot Number: G2171408E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 08/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2008
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 96 KG