MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG BICON ME/ME ME/PE INSERT STD 3/28NON-CEM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 75003618

Device Problem Biocompatibility (2886)

Patient Problems Inflammation (1932); Joint Dislocation (2374); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery was performed on (b)(6) 1999, the patient experienced soft tissue affections and metallosis.A revision surgery was performed due to the tendency to dislocate on an undisclosed date in 2012 to treat this adverse event in which the insert and the head were exchanged while the stem and the shell remained.At this time there's no further information available.

Manufacturer Narrative

Additional information: d6b (adding explantation date as best estimate date, revision surgery date is unknown), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, after a total hip replacement surgery was performed, the patient experienced soft tissue affections and metallosis.A revision surgery was performed due to the tendency to dislocate to treat this adverse event in which the insert and the head were exchanged while the stem and the shell remained.At this time there's no further information available.The device used in treatment was not returned for investigation.A product evaluation was not possible.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use (lit.No.12.23, ed.03/21) states metal related pathology as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.The available medical documents were reviewed.Granuloma can be seen as a result of chronic inflammation.The reported, ¿tendency to dislocate¿ can be seen as result of the reported metallosis.However, metallosis can also lead to accelerated wear and result in a ¿tendency to dislocate.¿ with the information provided the clinical root cause of the metallosis cannot be confirmed.The patient impact is the reported metallosis, dislocation associated symptoms and treatments, revision and expected transient post-op convalescence period.The performed investigation does not lead to an accurately determined cause.There is no evidence that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.There is no need for further actions.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.Corrected data: h6 (health effect - clinical code).

• Brand Name: BICON ME/ME ME/PE INSERT STD 3/28NON-CEM
• 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: 18119509
• MDR Text Key: 327928399
• Report Number: 9613369-2023-00213
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 07611996002928
• UDI-Public: 7611996002928
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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 Catalogue Number: 75003618
• Device Lot Number: 9811.52.2330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: METAL/METAL METAL BALL HEAD 28L, LOT#:9902.52.0255; PLUS BICON TITANIUM SHELL 3, LOT#:9904.130492; SL-PLUS STANDARD STEM 3 NON-CEMENTED, LOT#:9903.52
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female