MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN R3 CERAMIC LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number UNKNOWN

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 01/16/2023

Event Type  Injury  

Event Description

It was reported that, after a thr revision surgery had been performed approximately two (2) years ago due to a ceramic-on-ceramic bearing fracture, the patient required an additional revision surgery on (b)(6) 2023 due to unknown reasons.During this procedure, a 58mm/36mm r3 ceramic liner was implanted.Additional details related to this procedure are yet to be confirmed.

Manufacturer Narrative

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

Manufacturer Narrative

H10: additional information received by the manufacturer has been reviewed.The previously provided part number is not accurate, as there could be more than one ceramic liner combination for a 58 mm acetabular r3 shell.Additional information has been requested to the local office & hospital.Any additional findings will be eventually communicated.

Event Description

It was reported that, after a thr revision surgery had been performed approximately two (2) years ago due to a ceramic-on-ceramic bearing fracture, the patient required an additional revision surgery on (b)(6) 2023 due to an additional ceramic liner fracture.During this procedure, a 58mm/36mm r3 ceramic liner was implanted.Additional details related to this procedure are yet to be confirmed.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the patient had a second revision approximately two years after the first revision due to ceramic-on-ceramic liner fracture.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond that which has already been reported cannot be determined.No further clinical assessment can be rendered at this time.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, instructions for use, risk management file, prior actions and product prints review could not be performed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, size selected, surgical technique or postoperative care.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN R3 CERAMIC LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16457281
• MDR Text Key: 310403360
• Report Number: 1020279-2023-00431
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention