MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER 28 / C; LINER FLAT PE

Model Number	01.26.2839HCT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 march 2020.Lot 102331: (b)(4) items manufactured and released on 16-sep-2010.Expiration date: 2015-08-31.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 director: partial revision of primary cementless tha after almost 10 years due to pe wear on a patient who was (b)(6) years old at the time of index surgery.The eccentricity of the head is visible in the xray.Highly cross-linked polyethylene was used and only head and liner have been revised.This wear rate is not to be considered normal for highly cross-linked polyethylene, unless the head was scratched or third bodies were trapped in the articulation.No comment can be offered without technical analysis.Additional implants involved in the event, batch review performed on 19 march 2020.Cup: versafitcup cc 01.26.46mbtl acetabular shell cc light ø 46 lot.101043 (this item is not registered in usa).Lot 101043: (b)(4) items manufactured and released on 16-jun-2010.Expiration date: 2015-05-31.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.Stem: quadra-h 01.12.023 cementless, ha coated std stem size 3 ((b)(4)) lot.100766.Lot 100766: (b)(4) items manufactured and released on 22-jun-2010.Expiration date: 2015-05-31.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
Revision surgery performed 9 years and 4 months after primary surgery, due to eccentricity of the head.It was also found acetabular and proximal femur osteolysis.Suspected liner abrasion.Head and liner successfully revised.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d deprtment: from the received pieces, the liner seemed to be deformed and slightly reduced in dimensions.As confirmed by the analysis, the dimensions are lower than specification, most probably due to the sterilization in hospital and/or due to the medacta biowashing.From the received pieces and information, it is not possible to clearly determine the root cause of this event.Visual inspection performed by medacta medical affairs deprtment: the head was found to be finely scratched, in a rather uniform fashion, almost all over the entire articulating surface.This is compatible with one or multiple hard bodies of small dimensions possibly trapped in the articulation.It is not to be ascribed to the removal procedure.Of note, the scratches are numerous but shallow, compatible with the damages that can be provoked by several debris of medium-hardness material.Additional clinial evaluation performed by medacta medical affairs deprtment: the new radiographs made available did not carry any relevant additional information for the clinical evaluation.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER 28 / C
• Common Device Name: LINER FLAT PE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9863307
• Report Number: 3005180920-2020-00173
• Device Sequence Number: 2951973
• Product Code: LZO
• UDI-Device Identifier: 07630030807091
• UDI-Public: 07630030807091
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 08/31/2015
• Device Model Number: 01.26.2839HCT
• Device Catalogue Number: 01.26.2839HCT
• Device Lot Number: 102331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/21/2020
• Supplement Report FDA Received Date: 01/08/2021
• 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: 74 YR