MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX NEUT 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122136054

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Business unit: (b)(4).Date j&j became aware: 23/04/2018.Date of event: unknown.Name of reporter: (b)(6) clinical specialist depuy.Hospital name: (b)(6) hospital.Product name: marathon 36x54mm liner.Product code:1221-36-054.Lot/batch/exp: unknown.Was the product being used in a clinical trial? no.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? replacement implant used.Was there any consequence to the patient due to the event? no.Was the surgery prolonged due to the event? if yes, confirm how many minutes delay.No.Has the reporter facility indicated there may be legal action? no.Is the product available for return? yes.Please give a detailed explanation of the event: total hip replacement, surgeon insisted that marathon liner that was being used had a larger, internal diameter than stated (36mm internal ).He showed that a 36mm head seemed to not fit properly, within the 36mm liner.A replacement liner was used with no issue.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device finds nothing outward to suggest product error.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALTRX NEUT 36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 7530415
• MDR Text Key: 108805937
• Report Number: 1818910-2018-60119
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295016335
• UDI-Public: 10603295016335
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 122136054
• Device Lot Number: HM7078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• 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