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 Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Ambulation or Postural Difficulties (2544)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mitch trh md hd sz 50-4; cat# mmh-9988-0450; lot# fm074310 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.Product not returned.
Event or Problem Description
On (b)(6) 2022 in a patient was admitted to the surgical and orthopedic ward as an emergency as a result of a transfer by the emergency medical team.After an x-ray examination, the patient was found to have an abg stem fracture of the right hip.The abg stem in 2008.On (b)(6) 2022 revision surgery of the right hip joint was performed (removal of the abg endoprosthesis stem removal of the cap head.Open setting of the fracture with internal stabilization (femur)).Replacement of the stem and femoral head was performed.There is a drilling on the stem, (a hole) which was made to remove the stem during the surgery.
Event or Problem Description
On (b)(6) 2022 a patient was admitted to the surgical and orthopedic ward as an emergency as a result of a transfer by the emergency medical team.After an x-ray examination, the patient was found to have an abg stem fracture of the right hip.The abg stem in 2008.On (b)(6) 2022 revision surgery of the right hip joint was performed (removal of the abg endoprosthesis stem removal of the cap head.Open setting of the fracture with internal stabilization (femur)).Replacement of the stem and femoral head was performed.There is a drilling on the stem, (a hole) which was made to remove the stem during the surgery.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a abgii stem that was mated with a mitch head was reported.The event was confirmed via evaluation of the provided photograph.Method & results: product evaluation and results: no product was returned for evaluation however, a photograph were provided for review.The photograph shows a head and stem.The stem is fractured at the neck close to trunnion.Clinician review: no medical records were received for review with a clinical consultant.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: no product was returned for evaluation however, a photograph were provided for review.The photograph shows a head and stem.The stem is fractured at the neck close to trunnion.The exact cause of the event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15885896
• Report Number: 0002249697-2022-01745
• Device Sequence Number: 17467432
• 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: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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: 03/31/2013
• Device Model Number: 4845-0104
• Device Catalogue Number: 4845-0104
• Device Lot Number: CASE CODE: G2445972DID : 10185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2008
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Unknown
• Patient Weight: 89 KG