MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PINNACLE MTL INS NEUT28IDX48OD; HIP METAL ACETABULAR LINERS

Catalog Number 121889148

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2018

Event Type  Injury  

Manufacturer Narrative

(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

Clinical adverse event received for infection - deep.Event is serious and is considered severe.Event is has a remote possibility of being related to device and is definitely not related to procedure.Treatment includes irrigation and debridement as well as revision of the head and liner.Doi: (b)(6) 2002.Doe: (b)(6) 2018.Dor: (b)(6) 2018 (right hip).

Manufacturer Narrative

(b)(4).

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.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: PINNACLE MTL INS NEUT28IDX48OD
• Type of Device: HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7276461
• MDR Text Key: 100255122
• Report Number: 1818910-2018-53528
• Device Sequence Number: 1
• Product Code: OVO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121889148
• Device Lot Number: XNA-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 71