MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CERAMIC CERAMIC BALL HEAD 32M; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 75004173

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/28/2017

Event Type  Injury  

Event Description

It was reported that a hip revision surgery was performed due to sinking of the hip.Liner and ball head exchanged.

Manufacturer Narrative

Additional info: d10, d11, e2, e3, g7, g9, h2, h3, h6, h10 results of investigation: it was reported that a revision surgery was performed, due to sinking of the hip.The ball head (75004173) and the liner were exchanged.The surgeon stated that the patient suffered from a leg shortening.The ball head was revised with no further complications.The ex-planted device, used in treatment, was not returned for investigation.The production documentation as well as the complaint history review for the batch in scope did not show any deviations.Leg shortening is a known risk factor, mentioned in the instruction for use (lit.No.12.23, ed.05/16).Based on the received medical documents a medical assessment was conducted.The surgery report of the ball head revision did not indicate any inconsistencies related to the surgical technique.The risk of a unspecified post-operative condition is covered through our risk management.The investigation cannot conclude a root cause for the reported "sinking of the stem".With the information provided, the failure mode cannot be confirmed and the root cause stays undetermined after investigation.The failure mode and the device cannot be linked, as we did not receive the device for investigation.There are no indications that the implant failed to meet specifications at the time of manufacturing.Therefore, no further actions are deemed necessary at this point of the investigation.Smith and nephew will monitor the device for further similar issues.

• Brand Name: CERAMIC CERAMIC BALL HEAD 32M
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9395890
• MDR Text Key: 168642325
• Report Number: 9613369-2019-00097
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• 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: 03/13/2020

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: 06/03/2022
• Device Catalogue Number: 75004173
• Device Lot Number: C1505230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71331852 R3 SHELL 52MM, LOT: 15EM10601; 71336500 THREADED HOLE COVER, LOT: 15DM00995; 75100468 POLARSTEM, LOT: B1505937
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 122