MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 36MM +6; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Model Number	1365-36-230
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Joint Dislocation (2374); No Code Available (3191)
Date of Event	08/14/2020
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 posterior dislocation.Event is serious and is considered severe.Event is definitely related to device and not related to procedure.Date of implant: (b)(6) 2013.Date of event: (b)(6) 2020; (right hip).Treatment: closed reduction.
Event or Problem Description
On (b)(6) 2013, the patient underwent a primary right hip arthroplasty with no indicated intra-operative complications.On (b)(6) 2020, the patient presented to the emergency department following a fall after tripping over a dog and twisting the hip.The right hip became dislocated and the patient underwent a closed reduction in the emergency department.It was indicated that the patient was experiencing pain due to the dislocation.There is no evidence of revision.
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.Provided patient x-rays have been reviewed.It was not possible to confirm the reported dislocation event or a root cause.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.

• Brand Name: DELTA CER HEAD 11/13 36MM +6
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10489852
• Report Number: 1818910-2020-19442
• Device Sequence Number: 14157244
• Product Code: LZO
• UDI-Device Identifier: 10603295033585
• UDI-Public: 10603295033585
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2020

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: 1365-36-230
• Device Catalogue Number: 136536230
• Device Lot Number: 3600619
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 08/21/2020; 10/15/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/11/2020; 10/16/2020
• 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: ALTRX +4 NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 54MM; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18; ALTRX +4 NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 54MM; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 104