MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM STD SIZE 7; CEMENTLESS HIP STEM

Model Number	01.36.047
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 22 june 2020: lot 1906302: (b)(4) items manufactured and released on 28-nov-2019.Expiration date: 2024-11-19.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.
Event or Problem Description
Crack detected at the calcar 1 month after the primary surgery ((b)(6) 2020).In (b)(6) the surgeon noticed an ossification on the crack ( bone growth).The stem was mobilized and the mobilization occurred before the crack.The revision surgery is not scheduled at this moment and there is no information if it will be performed in the future.
Additional Manufacturer Narrative
On (b)(6) 2020 we were informed that the patient underwent primary surgery on (b)(6) 2020 with sms rod placement on (b)(6) 2020 we were also informed that: the patient has always been painful and seen again in teleconsultation during confinement on (b)(6) 2023 still painful.Carrying out a scanner on (b)(6) 2020 with evidence of cracking of the lesser trochanter (b)(6) 2020 pain but no traumatic lesion of the lesser trochanter on bone scintigraphy (b)(6) 2020 performed a sterile hip puncture but decision to resume pth on (b)(6) 2020 following a tilting of the sms rod.On (b)(6) 2020 we received further confirmations that: the stem was mobilized and the surgeon performed a revision surgery on (b)(6) 2020 and revised all implants, the correct date of primary is (b)(6) 2020 (not (b)(6) 2020 as initially reported).
Event or Problem Description
Crack detected at the calcar 1 month after the primary surgery ((b)(6) 2020).In june the surgeon noticed an ossification on the crack ( bone growth).The stem was mobilized and the mobilization occurred before the crack.On (b)(6) 2020 the surgeon performed a puncture.Revision surgery of all implants performed on (b)(6) 2020.

• Brand Name: STEM: SMS SOLID SMS SOLID STEM STD SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10256655
• Report Number: 3005180920-2020-00395
• Device Sequence Number: 14223908
• Product Code: LZO
• UDI-Device Identifier: 07630030888663
• UDI-Public: 07630030888663
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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 Expiration Date: 11/19/2024
• Device Model Number: 01.36.047
• Device Catalogue Number: 01.36.047
• Device Lot Number: 1906302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: Other; Required Intervention
• Patient Weight: 92