MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATUNE PRESSFIT STR STEM12X60MM; KNEE STEMS

Catalog Number 151312060

Device Problems Loss of Osseointegration (2408); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 02/21/2019

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.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Patient reported with painful and unstable right tka from an outside hospital with no available operative report.Xrays indicated a subsided and loose tibial component with a stem extension appearing to have exited the lateral tibial cortex.The surgical plan was to retain the well-fixed femoral component and revise only the tibial component and insert.Upon explanting the tibial component construct it became evident that the component was preoperatively misidentified by the surgical team as an mbt revision tibia and was actually an attune revision component.No instruments or implants were immediately available for the attune system.The attending surgeon, while being advised of the off-label nature of his decision, decided it was in the best interests of the patient to implant a sigma mbt revision rp 15mm buildup tray and to modify and utilize a sigma tc3 rp revision insert to articulate with the size 3 attune revision femoral component which resulted in a stable overall construct.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination, but based on the returned x-rays and photographs the reported loosening and migration could be confirmed.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUNE PRESSFIT STR STEM12X60MM
• Type of Device: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6107428552
• MDR Report Key: 8420588
• MDR Text Key: 138791979
• Report Number: 1818910-2019-87279
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295043546
• UDI-Public: 10603295043546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151312060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 04/19/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR