MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +12; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number	1365-36-340
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	02/27/2023
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 has been removed for confidentiality/privacy.The initial reporter is the patient.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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
"voluntary report received (mw5117500) patient called to report that approximately thirty days post surgery (left hip replacement), she experienced a hip dislocation (b)(6) 2023 despite following protocol for recovery.She was hospitalized and administered morphine for excruciating pain and numbness and was not able to walk for a while (non-weight bearing).On (b)(6) 2023 she experienced another hip dislocation (same side) and was taken to the hospital by fire and rescue and subsequently had surgical intervention to relocate the prosthetic hip.On (b)(6) 2023, she had additional surgery for the implant liner to be replaced as well as placing a larger cup to accommodate the liner and has been confined to her bed.Patient states that she still has "stabbing pain" in her hip and cannot walk without her cane when standing.She is still recovering from these events.This experience has forced her to retire from work and has caused her to have depression." doi- unknown.Dor- (b)(6) 2023.Affected side- left hip.
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.
Event or Problem Description
The patient stated that since filing the voluntary report, she is recovering well and her pain has significantly decreased.She clarified that the first surgery was a closed reduction and that the head and liner were replaced during the revision.She has no further questions or concerns at this time.
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: a1, a3, b5, d10, g4 and h4 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D1, d2 and d4.

• Brand Name: DELTA CER HEAD 12/14 36MM +12
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 17022261
• Report Number: 1818910-2023-11162
• Device Sequence Number: 11464526
• Product Code: LZO
• UDI-Device Identifier: 10603295033646
• UDI-Public: 10603295033646
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2023
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1365-36-340
• Device Catalogue Number: 136536340
• Device Lot Number: 3880010
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 06/02/2023; 06/12/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/09/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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: ACTIS COLLARED HIGH SIZE 1; ALTRX NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +12; PINNACLE BONE SCREW 40 MM; PINNACLE SECTOR II CUP 52MM; UNKNOWN HIP ACETABULAR LINERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female