MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK; CEMENTLESS HIP STEM

Model Number	01.12.23SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2018: lot 177576: (b)(4) items manufactured and released on 12 march 2018.Expiration date: 2023-03-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional product implanted in primary, not explanted during the additional surgery: cup: mpact 01.32.152dh acetabular shell ø52 two-holes (k132879), lot 172585: (b)(4) items manufactured and released on 03 october 2017.Expiration date: 2022-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on sep 4, 2018: intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
On (b)(6) 2018 the agent was in theatre with the surgeon who informed him that the patient was found to have a gt fracture immediately after primary case.The intra-op x-ray taken during primary didn't show any evidence of fracture with trial implants in place.However the post op xray in recovery showed a possible gt fracture.The patient was sent off for ct scan and it was confirmed there was femur, gt and pelvic fracture.A medacta rep attended the primary case and said there was nothing untoward during the procedure, patient was not overweight and there was no mention of fracture during the procedure or underlying extensive disease bone disease.The surgeon stated that the patient had avn.The patient was reoperated on (b)(6) 2018: no medacta implant was revised, but only cables were applied.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7897542
• Report Number: 3005180920-2018-00716
• Device Sequence Number: 1797774
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 03/04/2023
• Device Model Number: 01.12.23SN
• Device Lot Number: 177576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/21/2018
• 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: Required Intervention
• Patient Age: 39 YR