MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 28 +15.5 WH; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-15-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2021
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.
Event or Problem Description
Clinical adverse event received for recurrent dislocations event is not serious and is considered moderate event is possibly related to both device and procedure.Date of implantation: (b)(6) 2020 date of event (onset): (b)(6) 2021 (left hip).Treatment: brace and continued observance of hip precautions.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Examination of the provided x-ray images does find a dislocation event depicted in one of three images.Nothing indicative of a product problem is identified.It is noted that this depuy femoral head has been used in conjunction with competitor manufactured acetabular devices.This use of the depuy device is not recommended and is considered off label use.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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Office notes (b)(6) 21 indicate the patient has been experiencing pain, instability, subluxations and previous posterior dislocation.It was noted that for the (b)(6) 2021 dislocation the patient had a closed manipulation / reduction in the er and was then braced.No additional intervention at this time, surgeon indicates the plan is to treat conservatively.
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: b5 and h6 (clinical codes).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the joint injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h1 and h6 (impact code).

• Brand Name: ARTICUL/EZE BALL 28 +15.5 WH
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11831209
• Report Number: 1818910-2021-10387
• Device Sequence Number: 14172733
• Product Code: JDI
• UDI-Device Identifier: 10603295033134
• UDI-Public: 10603295033134
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K883460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/03/2021

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: 1365-15-000
• Device Catalogue Number: 136515000
• Device Lot Number: D19072249
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/01/2021; 06/02/2021; 06/23/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/08/2021; 06/22/2021; 06/24/2021
• 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: ARTICUL/EZE BALL 28 +15.5 WH.; STRYKER.; UNKNOWN HIP FEMORAL STEM.; ARTICUL/EZE BALL 28 +15.5 WH; STRYKER; UNKNOWN HIP FEMORAL STEM
• Patient Age: 70 YR
• Patient Weight: 88