MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP TIB BASE SZ 7 CEM; KNEE TIBIAL TRAY

Catalog Number 150610007

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 03/16/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Rec'd 22apr2016, right knee; ae/pain.For study knee: yes.Not serious, moderate severity, not device or procedure related.Treatment: physical therapy.Outcome: recovering/ resolving.Diagnosis for primary knee surgery: osteoarthritis.Cement - heraeus medical.Reopened complaint - rec'd 16 march 2017 - right knee - an ae for osteolysis was received.The ae is not serious, is of mild severity, is possibly device related, and not procedure related.The ae was treated with physical therapy and observation.Primary diagnosis: osteoarthritis.Update dec 14, 2017 additional information received.Clinical der states that an ae for tibial base loosening.The ae is considered serious, is severe, is possibly device related, and not procedure related.The ae was treated with revision of the tibial component on dec 11, 2017.This complaint was updated on dec 20, 2017.

Manufacturer Narrative

(b)(4).Investigation summary: a review of the complaint identified that it was completed 05-may-2017 and then re-opened 20-december-2017.A review of the information identified no additional investigational inputs.No further investigation was required and no changes were required to the previous investigation conclusions.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).Investigation summary: a review of the complaint identified that it was completed (b)(4) 2017 and then re-opened (b)(4) 2017.A review of the information identified no additional investigational inputs.No further investigation was required and no changes were required to the previous investigation conclusions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: rec'd (b)(4) 2016, right knee; ae/pain.For study knee: yes.Not serious, moderate severity, not device or procedure related.Treatment: physical therapy.Outcome: recovering/ resolving.Diagnosis for primary knee surgery: osteoarthritis.Cement - (b)(6) medical.Re opened complaint - rec'd (b)(4) 2017 - right knee - an ae for osteolysis was received.The ae is not serious, is of mild severity, is possibly device related, and not procedure related.The ae was treated with physical therapy and observation.Primary diagnosis: osteoarthritis / | investigation method: investigation methods: was patient affected: yes.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: yes.Product checked: no.Label checked: no.Product pulled from stock for inspection: no investigation results: the complaint was received on (b)(4) 2016.A complaints search on the above codes identified previous complaints received for pain.A lot specific search did not identify any other complaints.The x-rays were reviewed compact-(b)(4) which states the x-rays have been reviewed per wi-7915.No implant fracture or implant disassociation were identified.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.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Addendum added (b)(4) 2017.The complaint was reopened as further information was received; an ae for osteolysis was received.The ae is not serious, is of mild severity, is possibly device related, and not procedure related.The ae was treated with physical therapy and observation no further actions are identified./ | investigation summary: conclusion and justification status: the complaint states rec'd (b)(4) 2016, right knee; ae/pain.For study knee: yes.Not serious, moderate severity, not device or procedure related.Treatment: physical therapy.Outcome: recovering/ resolving.Diagnosis for primary knee surgery: osteoarthritis.Cement - (b)(6) medical.A complaint database search did not identify any anomalies.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419.Addendum added (b)(4) 2017.The complaint was reopened as further information was received; an ae for osteolysis was received.The ae is not serious, is of mild severity, is possibly device related, and not procedure related.The ae was treated with physical therapy and observation no further actions are identified.

• Brand Name: ATTUNE RP TIB BASE SZ 7 CEM
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7183041
• MDR Text Key: 96995049
• Report Number: 1818910-2018-10037
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042617
• UDI-Public: 10603295042617
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150610007
• Device Lot Number: 8017959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 78