MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN BICON-PLUS HIP INSTR; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01400253

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

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 02/26/2009

Event Type  Injury  

Event Description

It was reported that the patient had primary implantation in 1991 (unknown if s+n components were used) and revised for first time on (b)(6) 2004 where s+n components were implanted.Then, a second revision was performed due to unknown reasons where the stem and head were exchanged (reported under case- (b)(4)).Later, a third revision was performed due to cup loosening, change of ceramic head 32 l (case-(b)(4)) and the bicon size 6 cup (case-(b)(4)) to metal 32xl.

Manufacturer Narrative

H3, h6: it was reported that the patient had primary implantation in 1991 (unknown if s+n components were used) and revised for first time on april 01, 2004 where s+n components were implanted.Then, a second revision was performed due to unknown reasons where the stem and head were exchanged.Later, a third revision was performed due to cup loosening, change of ceramic head 32 l and the bicon size 6 cup to metal 32xl.The following report describes the performed investigations for the reported unknown bicon-plus size 6 cup, which intent use is in treatment.To date no information got available which implant type was used.It was only stated that it was a size 6.Furthermore no batch number was communicated and the article was not returned for investigation.A thorough product history review could not be performed.The risk of implant loosening is covered in our current risk file, and rated as low, as well as mentioned in our instruction for use for hip implants [lit.12.23, ed.05/16].All documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.In addition based on the available information the root medical cause for the loosening that precipitated the third revision surgery cannot be concluded.No probable cause can be determined.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.A relationship between the reported event and the device cannot be confirmed.Should additional information like adequate clinical documentation, batch number or the part itself get available further investigations can be planned.S+n will monitor this device for similar issues.

Manufacturer Narrative

After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that: the patient had primary implantation in 1991 (unknown if s+n components were used) and revised for first time on (b)(6) 2004 where s+n components were implanted.Then, a second revision was performed due to unknown reasons where the stem and head were exchanged (reported under (b)(4).Later, a third revision was performed due to cup loosening, change ceramic head 32 l (concomitant) and of bicon size 6 cup (b)(4) to metal 32xl.However, after further clarification and information received, it was determined that the issue had already been previously reported (under our reference number (b)(4) and report number (b)(4) therefore, it was determined that this case will be covered under the first report sent (b)(4).If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: UNKN BICON-PLUS HIP INSTR
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• MDR Report Key: 11605726
• MDR Text Key: 243614132
• Report Number: 9613369-2021-00139
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01400253
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention