MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX54OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881754

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  malfunction  

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

Details - upon attempting to implant the item described below.(b)(6) admitted he had maligned the insert to the shell which resulted in a small fragment of the ceramic liner popping off.Whilst trying to remove the liner to correct alignment a few more cracks appeared and then the liner crumbled.Leaving broken ceramic fragments in the acetabulum.All fragments were retrieved successfully and mr shaw stated no adverse outcomes are anticipated.Date j&j became aware: 12/9/19.Date of event: (b)(6) 2020.Name of reporter: (b)(6).Hospital name: (b)(6).Hospital town: (b)(6).Product name: pinnacle ceramic liner 54x36mm 121881754.Lot/batch/exp: 9137060.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? no.Was the product being used in a clinical trial? no.Event outcome/how was it managed? retrieved all of broken implant from patient.Assessed pinnacle shell for damage and concluded ok to proceed.Used another 54x36mm ceramic liner from the shelf.Was there a patient impact or was the procedure extended greater than 30 minutes due to the failure? no.Has the reporter facility indicated there may be legal action? no.Is the product available for return? yes.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

Event Description

Additional information received indicating that the affected side was right hip.

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.

Event Description

Additional information received indicating that the affected side was left hip and surgical delay of 20 minutes.

• Brand Name: EA DELTA CER INSERT 36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 9156203
• MDR Text Key: 217452976
• Report Number: 1818910-2019-107779
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881754
• Device Lot Number: 9137060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• 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