MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CERAMIC CERAMIC INSERT STANDARD 44/36; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC, CEMENTED

Catalog Number 75007454

Device Problem Fracture (1260)

Patient Problem Hip Fracture (2349)

Event Date 12/06/2018

Event Type  Injury  

Event Description

It was reported a revision surgery due to breakage of the mpf insert.It is unknown if all components were explanted.

Manufacturer Narrative

Results of investigation: a revision surgery due to a breakage of a ceramic insert was reported.One ball head and fragments of the insert were returned for investigation.A review of the corresponding production documentation did not detect any deviation from the standard manufacturing processes.The density of the insert was measured and is complying with the delivery specification of biolox forte components.Due to secondary damage and missing fragments the primary fracture surface and the primary metal transfer on the insert taper cannot be evaluated comprehensively.Extensive abrasion and secondary metal transfer on the ball head surface indicate a prolonged contact with the metal cup and the fractured insert prior to revision surgery.A review of complaint history did not reveal any other complaint for this batch of inserts.The revision was performed 9.5 years post implantation.All medical documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Despite the investigation performed the root cause of the reported issue remain undetermined.There is to the best of our knowledge no indication that the device failed to meet specification at the time of manufacturing.No further actions have been initiated.If additional information becomes available this complaint will be reopened.

• Brand Name: CERAMIC CERAMIC INSERT STANDARD 44/36
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 8200584
• MDR Text Key: 131544753
• Report Number: 1020279-2018-02914
• Device Sequence Number: 1
• Product Code: LPF
• Combination Product (y/n): N
• 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: 04/16/2019

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: No Information
• Device Expiration Date: 11/09/2015
• Device Catalogue Number: 75007454
• Device Lot Number: C0808146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART:75001149/MPF SHELL TRIO/LOT: B0815183; PART:75002074/POLARSTEM STEM/LOT: B0810249; PART:75007442/BIOLOX FORTE HEAD/LOT: B0900956; PART:75001149/MPF SHELL TRIO/LOT: B0815183; PART:75002074/POLARSTEM STEM/LOT: B0810249; PART:75007442/BIOLOX FORTE HEAD/LOT: B0900956
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR