MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54; CEMENTLESS HIP SHELL

Catalog Number	01.26.45.0054
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: partial hip (cup, liner and head) revision surgery occurred 5 years after implantation in a (b)(6) year-old woman.Hip dislocated after soft tissue release due to psoas impingent.In the radiographic image provided, the cup is apparently very big and anteversion does not look correct (it may have shifted immediately after primary implantation).The reasons that led to this position and dimension are not known: patient's anatomy that cannot be assessed having a single pre-revision x-rays may be one possibility.There is no reason to suspect a faulty device.Batch review performed on oct 19, 2018: lot 130761: (b)(4) items manufactured and released on 26 april 2013.Expiration date: 2018-03-31.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.Additional component revised: liner: cc and cc light 01.26.3644hct flat pe hc liner ø 36/ e, lot: 130726: (b)(4) items manufactured and released on 19 april 2013.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Implants from ceramtec 38.49.7179.285.00 biolox delta ceramic ball head 12/14 ø 36 size m 0 lot.825521 (not marketed in us).
Event or Problem Description
On september 20, 2018 we were informed that five years after the primary, the patient underwent to additional surgery due to psoas pain escalating in the past year and a soft tissue release was performed.Anterior cup impingement was noticed at that time.The patient has now presented a dislocation (5 years ans 3 months after primary surgery).The surgeon feels that the cup was too big, sat out of the acetabulum and the cup version was incorrect which would have been the source of soft tissue irritant.On (b)(6) 2018 the cup was replaced with a g7 dm cup.The stem remained and only a head change was required from medacta.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
• Common Device Name: CEMENTLESS HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7984665
• Report Number: 3005180920-2018-00804
• Device Sequence Number: 1707039
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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: 03/31/2018
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 130761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/19/2018
• 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: 73 YR