MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 5; HIP UNCEMENTED STEM

Model Number	01.18.175
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 march 2020: lot 180060: (b)(4) items manufactured and released on 19-apr-2018.Expiration date: 2023-04-11.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 devices involved: batch reviews performed on 12 march 2020: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 32 size m 0 (k112115) lot 186539: (b)(4) items manufactured and released on 27-nov-2018.Expiration date: 2023-11-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Liner: mpact 01.32.3241hct flat pe hc liner 32/d (k103721) lot 186964: (b)(4) items manufactured and released on 25-oct-2018.Expiration date: 2023-10-09.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 medacta medical affairs director: revision tha performed after an unspecified length of time since primary surgery.According to report, causes for revision are pain and extra-articular impingement.The latter cannot be determined by looking at the frontal xray.The cause of pain is not specified.The image supplied shows an acetabular cup protruding beyond the medial acetabular wall, which could well be a cause of pain and contribution to shortening the leg and causing extra-articular impingement.The history of this acetabular protrusion is not known.The stem was reported to be well integrated, the reason for removal was not specified.Apparently, the protruded cup has been left in place.There is no hint that a defective device has caused this problem.
Event or Problem Description
Revision surgery performed about 1 year after primary (the exact primary date is unknown) due to pain and extra-articular impingement (greater trochanter and proximal rim of acetabulum).Stem and head have been replaced due to pain.Also the liner have been swapped.Stem was proximally well integrated (where there is the coating) and distally loose (in general not a stem loosening because is a proximal fixation stem).

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 5
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9909844
• Report Number: 3005180920-2020-00199
• Device Sequence Number: 19651362
• Product Code: LZO
• UDI-Device Identifier: 07630030804403
• UDI-Public: 07630030804403
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161635
• 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): 04/01/2020

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: 04/11/2023
• Device Model Number: 01.18.175
• Device Catalogue Number: 01.18.175
• Device Lot Number: 180060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 04/01/2020
• 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: 64 YR