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

Catalog Number 75013984

Device Problems Loss of Osseointegration (2408); 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 (b)(4)).Later, a third revision was performed due to cup loosening, change of ceramic head 32 l ((b)(4)) and the bicon size 6 cup ((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 (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.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 ceramic head 32 l, which intent use is in treatment.To date 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 and adverse event without identified device or use problem is covered in our current risk file, and rated as low.The stated reason for revision was "cup loosening", therefore the relevant investigation took place in the third revision.The risk of "implant loosening" is also mentioned in the corresponding risk file for bicon plus implants and is rated as low.The risk is 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, the root medical cause for the loosening that precipitated the third revision surgery cannot be concluded.The cause is not established.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.

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 (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.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

After further assessment of the information gathered by the manufacturer, it was identified that this complaint has to be opened against an unkn.Bicon-plus implant (unkn.Part), since the orginal information stated that the revision surgery was performed due to cup loosening.Therefore, the ceramic ceramic ball head 32l was left as a concomitant device.

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 (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-2021-00046211).Later, a third revision was performed due to cup loosening, change of ceramic head and the bicon cup (b)(4).The following report describes the performed investigations for the reported plus bicon titanium shell 6 (article no.: 75013984; lot no.: 0312.60.4274), which intent use is in treatment.The specific device was not returned for investigation.The production record were reviewed.No deviation was found which could have led to the reported failure.For the specific batch in scope one additional complaint and for the specific article number one additional complaint were recorded, which also reported a loosening of the cup.Nevertheless this specific product is on phase out since 2005 and the design was revised.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.At that time no conclusion for the occurred failure can be made.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Therefore no corrective and preventative actions are being taken.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.The root cause can not be established and no device problem is found.Should additional information get available in future, this case will be re-assessed.S+n will monitor this device for similar issues.D4.

• Brand Name: UNKN. BICON-PLUS IMPLANT (UNKN. PART)
• 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: 11605708
• MDR Text Key: 243532873
• Report Number: 9613369-2021-00138
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: K070928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2021

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: 75013984
• Device Lot Number: 0312.60.4274
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 05/11/2021; 05/24/2021; 07/08/2021
• Supplement Dates FDA Received: 05/19/2021; 05/28/2021; 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CERAMIC CERAMIC BALL HEAD 32L
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 79