MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG METAL METAL BALL HEAD 22L CONE 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 75004157

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 10/08/2019

Event Type  Injury  

Event Description

It was reported a revision surgery, performed due to disassociation.Ball head (cocr) and stem (sl-plus) were removed.

Manufacturer Narrative

It was reported a revision surgery, performed due to disassociation.Ball head (cocr) and bipolar head, used in treatment, were removed and sent back for investigation.He ball head shows only small signs of wear and tear.In contrast to the prosthesis, where some scratches are visible on the polished surface.The shell includes the pe inlay.The retaining pe-ring is really worn down and shows heavy wear.It is assumed that there was a heavy friction between metall ball head and retaining ring.Dislocation of hip implants e.G.Ball heads is a known side effect and is described in our ifu for hip implants 12.23.No other complaint found for the reported batch numbers b0711396 and c0800173.No deviation according to manufacturing specification found in the corresponding batch records.Nevertheless, medical records were not provided therefore a thourough clinical investigation couldn't be performed and the root cause couldn't be determined.If further information get available the complaint will be re-assessed.S+n will monitor this device for further investigations.

• Brand Name: METAL METAL BALL HEAD 22L CONE 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar TN 06340 ; SZ 06340
• MDR Report Key: 9311407
• MDR Text Key: 166039200
• Report Number: 1020279-2019-03952
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K001942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2015
• Device Catalogue Number: 75004157
• Device Lot Number: C0800173
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 11/11/2019; 11/11/2019
• Supplement Dates FDA Received: 11/26/2019; 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention