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

Catalog Number	151312060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient had swelling and it was loose in knee.Patient had x-rays and it was confirmed that it was loose.Not infected had bloodwork done to make sure.Patient was taking naproxen 500 mg for the swelling and to help with the pain and meds were prescribed by surgeon.Patient was also taking methocarbamol for muscle spasms 500 mg.Patient ice most evenings for swelling and pain.Patient had a hard time walking.This was a full right knee replacement performed by surgeon at hospital.Patient had since retired.So patient saw another doctor local just for x-rays and to get some meds.Patient should not have another surgery so soon and be in this kind of pain.
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 (mre), was not possible because the required lot code was not provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
The patient provided additional information via email stating "yes it is my 2019 knee replacement that has come loose.I am scheduled for right knee replacement surgery in oct.X-rays have shown the femoral part is definitely loose and is causing pain and i have problems walking.Please let me know when you find out if recalled and what can be done.
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 was performed for the finished device lot number: h75194, product code: (b)(4) and no [non conformances /manufacturing irregularities] were identified.
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d4 (lot, catalog, expiration date, udi), e1 (facility name), g4 (pma/ 510(k).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d10 (concomitant), h6 health effect - impact code.
Event or Problem Description
Medical records received.On (b)(6) 2019, the patient had a revision right total knee to address loosening of hardware of right knee.No mention of manufacturer of components revised.Right knee implants that were implanted on (b)(6) 2019 were depuy products.

• Brand Name: ATUNE PRESSFIT STR STEM12X60MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17216564
• Report Number: 1818910-2023-13241
• Device Sequence Number: 6176689
• Product Code: JWH
• UDI-Device Identifier: 10603295043546
• UDI-Public: 10603295043546
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/28/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151312060
• Device Lot Number: H75194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 07/27/2023; 08/15/2023; 09/13/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/14/2023; 08/15/2023; 08/22/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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: ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE PS FEM RT SZ 5 NAR CEM.; ATTUNE PS RP INSRT SZ 5 8MM.; ATUN TIB SLV M/L 29MM FULL POR.; ATUNE REV RP TIB BASE SZ 4 CEM.; UNK ATTUNE FEMORAL.; UNK ATTUNE KNEE TIBIAL TRAY.; UNKNOWN KNEE PATELLA.; UNKNOWN KNEE TIBIAL INSERT.; UNKNOWN KNEE TIBIAL SLEEVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female