MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 2; HIP CEMENTLESS STEM

Catalog Number	01.18.142
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2019: lot 100546: (b)(4) items manufactured and released on 19 april 2010.Expiration date: 2015-05-31.No anomalies found related to the issue.To date, all the items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs department: stem revision surgery performed about 8 years after cementless total hip arthroplasty in a (b)(6) year old man with a history of dair.Radiographic images provided show the presence of bone alterations including heterotopic ossification and osteolytic regions around the stem.Radiographic alteration may be suggestive of an infective process but also suboptimal position of the cup may have caused impingement.The reason of this event cannot be determined on the basis of information received.Other devices were involved in the complaint.Batch review performed on 18 june 2019: implants from ceramtec 38.49.7175.455.00 biolox delta ceramic ball head 12/14 ø 28 size m 0.Lot.681412 (not registered in usa).Manufacturing process review performed by ceramtec: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilisation.Due to a lack of ceramic parts further investigations cannot be done.Cup: versafitcup 01.26.52mb acetabular shell ø 52 lot.103044 (k083116).Batch review performed on 18 june 2019: lot 103044: (b)(4) items manufactured and released on 17 november 2010.Expiration date: 2015-09-30.No anomalies found related to the issue.To date, all the items of the same lot have been already sold without any similar reported event.Liner: versafitcup dm 01.26.2852m double mobility liner ø 52/28 lot.104182 (k083116).Batch review performed on 18 june 2019: lot: 104182: (b)(4) items manufactured and released on 16 february 2011.Expiration date: 2015-12-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 8 years after primary the surgeon revised the patient for a hip infection.The surgeon revised all the device successfully.The infection type is a morawietz (class unknown).

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8721215
• Report Number: 3005180920-2019-00500
• Device Sequence Number: 16645207
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• 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 Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: 05/31/2015
• Device Catalogue Number: 01.18.142
• Device Lot Number: 100546
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/21/2019
• 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: 77 YR
• Patient Weight: 73