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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY
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DEPUY IRELAND 9616671 ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY Back to Search Results
Catalog Number 150600007
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Adhesion(s) (1695); Pain (1994); Synovitis (2094); No Code Available (3191)
Event Date 02/02/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event Description
Revision of attune tibial plateau because of loosening.There has been no cement adhesion to the implant.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Investigation methods: was patient affected: yes.Device history reviewed: yes.Lot trace obtained: no.Complaints database searched: yes.Product checked: no.Label checked: no.Product pulled from stock for inspection: no.A review of complaint databases did not identify any anomalies.It should be noted that no device was returned product code 150600007, work order / lot 8422412 was manufactured on 29 november 2016.12 parts were manufactured per specification and all raw materials met specification.There is no deviation or nr associated with this lot the medical records were reviewed in a-236746 which states patient underwent a ct scan that denied osteolysis of the femoral component previously suggested by xray with no mention of osteolysis under the tibial component.The ct did suggest possible loosening of the tibial component.Patient was then revised on (b)(6) 2019 for pain.Loosening of the tibial tray at the cement/implant interface was confirmed during revision.Adhesions and synovitis were also found.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Product code 150600007, work order / lot 8422412 was manufactured on 29 november 2016.12 parts were manufactured per specification and all raw materials met specification.There is no deviation or nr associated with this lot.Device history batch = null.Device history review = null.
 
Event Description
Patient underwent a ct scan that denied osteolysis of the femoral component previously suggested by xray with no mention of osteolysis under the tibial component.Affected side: right.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).The device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot :product code 150600007, work order / lot 8422412 was manufactured on 29 november 2016.12 parts were manufactured per specification and all raw materials met specification.There is no deviation or nr associated with this lot.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ATTUNE FB TIB BASE SZ 7 CEM
Type of Device
ATTUNE IMPLANT : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key8390375
MDR Text Key137821916
Report Number1818910-2019-86440
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295042419
UDI-Public10603295042419
Combination Product (y/n)N
PMA/PMN Number
K101433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup,Followup
Report Date 02/13/2019
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 Health Professional
Device Catalogue Number150600007
Device Lot Number8422412
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Initial Date Manufacturer Received 02/13/2019
Initial Date FDA Received03/05/2019
Supplement Dates Manufacturer Received04/25/2019
05/21/2019
07/15/2019
Supplement Dates FDA Received05/07/2019
05/29/2019
07/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight92
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