MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 40IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-40-060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fluid Discharge (2686)

Event Date 03/18/2021

Event Type  Injury  

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 Description

It was reported that the sales consultant was called this am by the or that there was an i&d with the surgeon.He arrived just after the incision was made and was able to obtain some information regarding the case.This patient was told to come into the er to be admitted and would undergo a hip i&d.This patient had his hip replaced on (b)(6) 2021 at (b)(6) hospital and recently began experiencing redness and drainage from his wound.During the i&d the hip ball and pinnacle liner were explanted and exchanged for new products.The 7hi summit stem and 60mm pinnacle sector cup were left in situ.Doi: (b)(6) 2021, dor: (b)(6) 2021, 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 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 device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: ALTRX NEUT 40IDX60OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11619590
• MDR Text Key: 243949305
• Report Number: 1818910-2021-07148
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295393368
• UDI-Public: 10603295393368
• Combination Product (y/n): N
• PMA/PMN Number: K132959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 1221-40-060
• Device Catalogue Number: 122140060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 60MM PINNACLE SECTOR CUP; 7HI SUMMIT STEM; ALTRX NEUT 40IDX60OD; DLT TS CER HD 12/14 40MM +5.0; 60MM PINNACLE SECTOR CUP; 7HI SUMMIT STEM; ALTRX NEUT 40IDX60OD; DLT TS CER HD 12/14 40MM +5.0
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 199