MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG EP-FIT/MPF CERAMIC INSERT DELTA 52/32; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75001968

Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 08/18/2009

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that, after a thr surgery performed on (b)(6) 2009, a revision surgery was performed on (b)(6) 2009 due to irritation between the biolox delta ce ball head 12/14 36l and the ep-fit/mpf ceramic insert delta 52/32.Later on (b)(6) 2021 patient underwent another revision surgery due to a fracture of the nanos stem.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Results of investigation: it was reported that, after a thr surgery performed on (b)(6)2009, a revision surgery was performed on (b)(6) 2009 due to irritation between the biolox delta ce ball head 12/14 36l and the ep-fit/mpf ceramic insert delta 52/32.Since the revision took place in 2009, the devices, used in treatment were no returned for investigation.Therefore, the relationship between the reported event and the device cannot be confirmed.The production documentation of both devices was reviewed.There are no indications that the device failed to match specification at the time of manufacturing.The complaint history of the devices was reviewed.The risk profile of both devices is low and covered through the corresponding risk management files.The current ifu lists several potential adverse events and medical device problems which could have led or describe the discomfort / irritation at the insert/ball head interface.Review of past corrective actions was performed.No further escalation is required.Based on the provided information a medical assessment was conducted.The provided x-rays do not contribute to the root cause of the squeaking but it¿s a known symptom with a ceramic on ceramic articulation.With the information provided the clinical root cause of the ¿irritation and squeaking¿ cannot be confirmed, and it cannot be concluded that the reported events were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the available information the root cause stays undetermined after investigation.It cannot be speculated about contributing factors.To date, the need for further investigation is not indicated.Smith and nephew will monitor this device for further similar issues.

• Brand Name: EP-FIT/MPF CERAMIC INSERT DELTA 52/32
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13310677
• MDR Text Key: 284170918
• Report Number: 9613369-2022-00010
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2014
• Device Catalogue Number: 75001968
• Device Lot Number: A0604289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 01/05/2022; 03/21/2022
• Supplement Dates FDA Received: 03/11/2022; 04/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 75003896-EP-FIT PLUS SHELL TI-PLASMA 60 NON-CEM; 75008160-NANOS FEMORAL NECK PROSTHESIS NONCEM 6
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male