MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 40IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-40-458
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # : (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
Patient implanted on (b)(6) 2021.Known non-compliant patient, dislocation.Implanted a constrained liner.Did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? yes, facility name of original implant: doctors community, was device explanted? true, hardware/explant removal due to: dislocation.Did patient require revision surgery? true.If yes, date of revision surgery.(b)(6) 2021.Reason for revision surgery.Dislocation.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? xrays attached.Patient status/ outcome / consequences: yes.Patient consequence description/was there a clinical outcome experienced by the patient? dislocation.Surgery required, was other medical intervention required: yes, if yes, describe: revision, is the patient part of a clinical study? no.(b)(4).Device property of: none.Device in possession of: none.(b)(4).Device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the provided patient x-ray images does note a dislocation event.It has been reported that the patient is non-compliant to post surgery precautions.Nothing is identified indicative of a product problem.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
Additional information was received indicated that there was no surgical delay and the affected side involved in this event was the left hip.

• Brand Name: ALTRX +4 NEUT 40IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12041259
• Report Number: 1818910-2021-13250
• Device Sequence Number: 14453145
• Product Code: LPH
• UDI-Device Identifier: 10603295016601
• UDI-Public: 10603295016601
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 06/04/2021

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: 1221-40-458
• Device Catalogue Number: 122140458
• Device Lot Number: J38Y78
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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: ALTRX +4 NEUT 40IDX58OD; DLT TS CER HD 12/14 40MM +1.5; ALTRX +4 NEUT 40IDX58OD; DLT TS CER HD 12/14 40MM +1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR