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

Model Number	4845-0106
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	06/15/2020
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.
Event or Problem Description
A r abg stem and head was revised to a restoration modular stem.The reason given for the revision by the surgeon was periprosthetic fracture which led to loosening and subsidence of the stem.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture & subsidence involving abgii no6 cementless right v40 was reported.The event was confirmed based on medical review.Method & results: -device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays was rejected by a clinical consultant indicating: undated implant labels: 155/17 restoration modular stem, 19/0 v40 rest.Mod.Body, 32/-4 v40 biolox head.6/4/20 x-rays ap pelvis, lateral right hip: bilateral reduced uncemented tha.Left nominal, right comminuted periprosthetic fracture of the proximal femur with subsidence of prosthetic stem.No clinical or pmh, no operative reports, no examination of explanted components, no dated serial x-rays.While the x-rays confirm the event description, insufficient data is presented to create a medical report regarding this late term clinical situation.-device history review: 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 reported lot.Conclusion: it was reported that patient was revised due to periprosthetic fracture which led to loosening and subsidence of the stem.The event was confirmed based on medical review.A review of the provided medical records and x-rays was rejected by a clinical consultant indicating: undated implant labels: 155/17 restoration modular stem, 19/0 v40 rest.Mod.Body, 32/-4 v40 biolox head.6/4/20 x-rays ap pelvis, lateral right hip: bilateral reduced uncemented tha.Left nominal, right comminuted periprosthetic fracture of the proximal femur with subsidence of prosthetic stem.No clinical or pmh, no operative reports, no examination of explanted components, no dated serial x-rays.While the x-rays confirm the event description, insufficient data is presented to create a medical report regarding this late term clinical situation.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not available.
Event or Problem Description
A r abg stem and head was revised to a restoration modular stem.The reason given for the revision by the surgeon was periprosthetic fracture which led to loosening and subsidence of the stem.

• Brand Name: ABGII NO6 CEMENTLESS RIGHT V40
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• MDR Report Key: 10217266
• Report Number: 0002249697-2020-01359
• Device Sequence Number: 3233085
• Product Code: LPH
• UDI-Device Identifier: 07613327051018
• UDI-Public: 07613327051018
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• 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): 09/30/2020

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 Model Number: 4845-0106
• Device Catalogue Number: 4845-0106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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
• Patient Age: 73 YR
• Patient Weight: 56