MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-32-054

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Discomfort (2330); Joint Dislocation (2374)

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 Description

Revision of pinnacle liner and head.Was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> inflamation and discomfort.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc.Revision) required: yes.If yes, describe: pre op xrays.Is the patient part of a clinical study: no.Ip-01605784: device property of: none.Device in possession of: none.Ip-01605785: 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.

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: b1 (product problem), b5, h6 (clinical code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (medical device problem code).

Event Description

Additional information received indicated that the patient had experienced dislocation and discomfort.There was no infection and no tissue was sent to pathology.Affected side: right hip.

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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: ALTRX NEUT 32IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16022804
• MDR Text Key: 305891608
• Report Number: 1818910-2022-25898
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 1221-32-054
• Device Catalogue Number: 122132054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/21/2022; 12/29/2022
• Supplement Dates FDA Received: 12/23/2022; 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 32 +13 BLK
• Patient Outcome(s): Required Intervention
• Patient Sex: Male