MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 2; HIP FEMORAL STEM

Model Number	1010-11-020
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Corrected h6 health effect codes.
Event or Problem Description
It was reported that the patient had a loose femur.Surgeon thinks it was due to infection.Doi: unknown; dor: (b)(6) 2021: right hip.
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.H6 clinical code: removed appropriate term / code not available (e2402) which captures infection.
Event or Problem Description
Additional information received indicated that the surgeon suspected infection and took biopsies during the revision.Biopsy results revealed that the patient had bone cancer, not an infection.The femoral component was loose.
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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ACTIS COLLARED STD SIZE 2
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11543448
• Report Number: 1818910-2021-05739
• Device Sequence Number: 11710168
• Product Code: MEH
• UDI-Device Identifier: 10603295380429
• UDI-Public: 10603295380429
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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: 1010-11-020
• Device Catalogue Number: 101011020
• Device Lot Number: J1334N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/23/2021; 04/07/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 03/29/2021; 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACTIS COLLARED STD SIZE 2; ALTRX +4 10D 32IDX48OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +5; ACTIS COLLARED STD SIZE 2; ALTRX +4 10D 32IDX48OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +5
• Outcome Attributed to Adverse Event: Required Intervention