MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø28X48; METALLIC BIPOLAR HEAD

Catalog Number	25060.2848
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2017.Lot 155964: (b)(4) items manufactured and released on 28 december 2015.Expiration date: 2020-12-01.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.On 03 november 2017 the medical affairs director performed a clinical evaluation and commented as follows: immediate postoperative revision surgery due to dislocation.Radiographic image provided shows the dislocation of the bipolar head from the acetabulum.The initial position of the prosthetic components cannot be properly assessed having a single x-ray projection.Factors that can be related to this event may include traumatic events during patient mobilization, suboptimal implant position, status of soft tissues and muscular structures.On the basis of available information, there is no reason to suspect a faulty device.
Event or Problem Description
Patient dislocated whilst in recovery and returned to theatre 2 hours later to revise stem position and modify length of prosthesis.This was done via the anterior approach.Return to theatre was required to revise stem, head and bipolar options.Dislocation was noticed in recovery with routine post op x-ray.All implants were removed and replaced.

• Brand Name: BIPOLAR HEAD Ø28X48
• Common Device Name: METALLIC BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7047828
• Report Number: 3005180920-2017-00683
• Device Sequence Number: 16566767
• Product Code: KWY
• UDI-Device Identifier: 07630030843679
• UDI-Public: 07630030843679
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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: 12/01/2020
• Device Catalogue Number: 25060.2848
• Device Lot Number: 155964
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2017
• Initial Report FDA Received Date: 11/21/2017
• 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 Weight: 70