MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO4 CEMENTLESS RIGHT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	4845-0104
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534)
Date of Event	09/07/2021
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.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.Not returned to the manufacturer.
Event or Problem Description
The patient reported to the hospital and was admitted to the orthopedics department due to pain and limb shortening.The performed diagnostics revealed incorrect positioning of the hip joint prosthesis components, in particular the stem and head (suspected stem fracture).During the revision of the hip arthroplasty, a partial fracture of the stem cone and significant abrasion on the surfaces of the stem cone, head and polyethylene insert was reported.During the revision procedure, the patient was fitted with the stryker system: restoration modular stem, ceramic head, polyethylene insert.Due to the correct seating, the acetabular element was left in the operator's decision.
Event or Problem Description
The patient reported to the hospital and was admitted to the orthopedics department due to pain and limb shortening.The performed diagnostics revealed incorrect positioning of the hip joint prosthesis components, in particular the stem and head (suspected stem fracture).During the revision of the hip arthroplasty, a partial fracture of the stem cone and significant abrasion on the surfaces of the stem cone, head and polyethylene insert was reported.During the revision procedure, the patient was fitted with the stryker system: restoration modular stem, ceramic head, polyethylene insert.Due to the correct seating, the acetabular element was left in the operator's decision.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a abgii stem that was mated with an lfit v40 cocr head was reported.The event was confirmed.Method & results: product evaluation and results: the metal head and the mated stem were returned for evaluation.The stem was fractured at the neck close to trunnion.Significant wear damage was noticed within the metal head taper area and on the stem trunnion.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The stem fractured in overload at the point of wear.This has been documented as part of a capa.No further material analyses were performed.Clinician review: no medical records were received for review with a clinical consultant.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 due to pain and limb shortening.During the surgery it was noticed that a partial fracture of the stem cone and significant abrasion on the surfaces of the stem cone, head and polyethylene insert.The metal head and the mated stem were returned for evaluation.The stem was fractured at the neck close to trunnion.Significant wear damage was noticed within the metal head taper area.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The stem fractured in overload at the point of wear.This has been documented as part of a capa.No further material analyses were performed.The reported abg ii stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of a nc and capa.No further investigation for this event is required at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ABGII NO4 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12553241
• Report Number: 0002249697-2021-01649
• Device Sequence Number: 14568050
• Product Code: LPH
• UDI-Device Identifier: 07613327050950
• UDI-Public: 07613327050950
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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: 01/31/2015
• Device Model Number: 4845-0104
• Device Catalogue Number: 4845-0104
• Device Lot Number: G2950529A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2010
• 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 Sex: Unknown