MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CERAMIC CERAMIC BALL HEAD 32M; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number 75004173

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 05/08/2020

Event Type  Injury  

Event Description

(b)(6).It was reported that a thr was performed in 2012.Patient was experiencing acute hip pain because of a twisted knee.No fall occurred.A broken ceramic head was diagnosed radiologically.Revision surgery was performed in (b)(6) 2020.

Manufacturer Narrative

Results of investigation: it was reported that patient was experiencing acute hip pain because of a twisted knee.No fall occurred.A broken ceramic head was diagnosed radiologically.No medical documentation was provided and a thorough medical assessment could therefore not be conducted.The part in question was returned for investigation.A visual investigation could confirm the fracture of the ball head, which intent use is treatment.A material assessment showed that microstructure of the material met the requirements.The expected primary metal transfer observed was not equally distributed on the cone of the ball head.This may indicate a disturbance at the interface between stem and ball head.The origin of the fracture cannot be determined, however the disturbance at the interface between the stem and the ball head, leading to an increase of mechanical stress, may have caused the fracture of the ceramic ball head.A document history review was performed and there were no deviations detected.There are no indications that the part failed to match specification at the time of manufacturing.A complaint history review revealed further complaints for the batch in question.The risk of a ball head fracture is covered through the corresponding risk management files.In the ifu (12.23.Ed 05/16), implant fractures are listed as potential risks.To date, based on available evidence, the need for further action is not indicated.Smith and nephew will monitor this device for further similar incidents.The device will be retained.

• Brand Name: CERAMIC CERAMIC BALL HEAD 32M
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10148224
• MDR Text Key: 194946580
• Report Number: 9613369-2020-00115
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K070928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2019
• Device Catalogue Number: 75004173
• Device Lot Number: C1140980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Distributor Facility Aware Date: 05/14/2020
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRAPLANT INSERT (THIRDPARTY) 96112 LOT: C110457; INTRAPLANT SHELL (THIRDPARTY) 96152 LOT: B110422; PART:75002756,SL-PLUS STEM,LOT:C1201441
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR