MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1219-36-060

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Anemia (1706); Unspecified Infection (1930); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 06/24/2010

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

Pfs and medical records received.Pfs alleges infection, dislocation, muscle damage and anemia.After the review of medical records for mdr reportability,patient was revised to address dislocation,status post complex right revision.Revision notes reported of anterior dislocation.Clinical notes reported of staph infection and purulent drainage.It was also reported that the patient has a right femoral fracture due to an accident but this will not be coded since it was not due to depuy product.Doi: (b)(6) 2010; dor: (b)(6) 2010; right hip.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Udi: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.

• Brand Name: PINN MAR NEUT 36IDX60OD
• 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: 7163980
• MDR Text Key: 96356938
• Report Number: 1818910-2018-50204
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014485
• UDI-Public: 10603295014485
• Combination Product (y/n): N
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2017

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 Expiration Date: 06/06/2012
• Device Model Number: 1219-36-060
• Device Catalogue Number: 121936060
• Device Lot Number: BX3AL1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/25/2018; 12/17/2018; 12/21/2020
• Supplement Dates FDA Received: 01/26/2018; 12/19/2018; 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 97