MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN PRESSFIT STR STEM18X110MM; KNEE STEMS

Model Number	1513-18-110
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised due to loosening of the femoral sleeve at the bone to implant interface.Cement manufacturer was unknown.This patient is very large is stature, has a bka on his contralateral limb and continues to smoke.He presents post surgically with pain in his thigh.Xrays show that the femoral sleeve has not ingrown and the stem appears to be broken at the stem-sleeve junction.Operatively, his implant was not ingrown and showed significant metalosis in the joint.Tissue are sent to pathology to rule out infection.The implant could be spun around once the insert was removed and this was concerning.Upon continued exploration and with removal of the femoral implant, it was found that the stem- sleeve junction was loose, not broken.A thorough debridement is performed and a long bowed cemented lps stem was placed uneventfully.The new pin that comes with the distal femoral component was utilized.No instruments were broken.Doi: (b)(6) 2021; dor: (b)(6) 2023; affected side: right knee.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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: a manufacturing record evaluation (nc search) was performed for the finished device product code : 151318110, lot number : j8656f and no non-conformances / manufacturing irregularities were identified.

• Brand Name: ATUN PRESSFIT STR STEM18X110MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16947746
• Report Number: 1818910-2023-10464
• Device Sequence Number: 20422124
• Product Code: JWH
• UDI-Device Identifier: 10603295043737
• UDI-Public: 10603295043737
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1513-18-110
• Device Catalogue Number: 151318110
• Device Lot Number: J8656F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATT REV SLV LPS FEM ADP +5; ATTUNE REV LPS INSRT XXSM 12MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN PRESSFIT STR STEM18X110MM; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 30MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 65 KG