MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3; UNCEMENTED HIP STEM

Catalog Number	01.12.033
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 march 2019: lot 100022: (b)(4) items manufactured and released on 17-mar-2010.Expiration date: 2015-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical director: partial hip revision surgery (stem, head and liner) occurred 8 years and 8 months after cementless total hip arthroplasty in a (b)(6) year old man affected by unknown comorbidities (asa 3).Radiographic image provided shows the presence of osteolytic regions around the stem and signs of stress shielding.Acetabular shell looks slightly anteverted but reasons of this position cannot be determined not having a preoperative x-ray.Some wear of polyethylene liner after almost 9 years is normal; the osteolytic response depends on individual factors.The reason of this event cannot be determined.Preliminary investigation performed by r&d project manager: from preliminary visual investigation, it is not possible to determine the implant's failure root cause.Explant is covered in biological fluids, hydroxyapatite layer almost completely absorbed after in situ time.Pe liner shows damages due to extraction and seems that a big debre detached from the liner during this operation.
Event or Problem Description
On the (b)(4) 2019 the complaint was notified reporting a revision surgery scheduled for the (b)(6) 2019.On the 28 february 2019 we become aware that the revision surgery was post poned on the (b)(6) 2019.On the (b)(6) 2019 the branch confirmed that the revision surgery was performed on the (b)(6) 2019.Revision surgery performed after 8 years and 8 months from the primary surgery due to stem loosening, left side.The cup was left in place, liner, head and stem have been revised (implanted a mectacer ceramic liner 32e, a mectacer ceramic ball head 32s and a quadra-r stem size 3).

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8443625
• Report Number: 3005180920-2019-00184
• Device Sequence Number: 2887978
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 03/22/2019

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: 02/28/2015
• Device Catalogue Number: 01.12.033
• Device Lot Number: 100022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/22/2019
• 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: 67 YR
• Patient Weight: 81