MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 3; CEMENTLESS HIP STEM

Model Number	01.18.143
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 6-jul-2020: lot 135044: (b)(4) items manufactured and released on 6-dec-2013.Expiration date: 31.10.2018.(b)(4) piece resterilized and released on 26.08.2016.Expiration date: 04.07.2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any other similar reported event since 2016.Additional implant involved: liner: cc e cc light 01.26.3244hct flat pe hc liner ø 32 / e (k103352) lot.136290.Batch review performed by medacta regulatory affairs department on 6-jul-2020: lot 136290: (b)(4) items manufactured and released on 12-feb-2014.Expiration date: 31.12.2018.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any other similar reported event since 2016.Preliminary investigation performed by r&d project manager: implants covered in biological fluids.Residual bone on distal stem.From preliminary visual analysis it is not possible to evaluate the possible root causes of the loosening.Clincal evaluation performed by medical affairs manager: partial hip (stem, head and liner) revision performed 6.5 years after cementless total hip arthroplasty in an elderly patient ((b)(6) year old).Bone formation is visible on the explanted stem surface.Images provided don't allow a proper clinical evaluation.No conclusion can be drawn on the basis of available information.
Event or Problem Description
Revision surgery performed after 6 years from the primary surgery (exact primary date is unknown, we know that it was performed in 2014) due to stem loosening (proximally) and suspicion of cup loosening.During the revision, the stem and liner were revised and the cup remains in place as it was well fixed.The liner 32mm was causing an impingement with the primary stem and it was revised to 36mme.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10307108
• Report Number: 3005180920-2020-00441
• Device Sequence Number: 824922
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 10/31/2018
• Device Model Number: 01.18.143
• Device Catalogue Number: 01.18.143
• Device Lot Number: 135044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/22/2020
• 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: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 80