MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE -3; HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

Model Number 1363-08-000

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

Patient Problem No Code Available (3191)

Event Date 11/01/2020

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

Patient had hemiarthroplasty performed (b)(6) 2020.Was brought back to operating room due to foreign body (cement) in acetabulum and subluxation.The femoral stem was not explanted.The stem was not loose and did not move.After foreign body removed it was determined the 47mm head was too large and a 46mm was then used.Tapered neck (-3) was also replaced.Intra op x-rays taken to confirm placement.

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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: TAPERED SPACER ARTICUL/EZE -3
• Type of Device: HEMI HIP IMPLANT : HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10843178
• MDR Text Key: 216338631
• Report Number: 1818910-2020-24662
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032663
• UDI-Public: 10603295032663
• Combination Product (y/n): N
• PMA/PMN Number: K903084
• 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: 11/01/2020

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: 1363-08-000
• Device Catalogue Number: 136308000
• Device Lot Number: J5130J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR CATHCART BALL 47MM OD; SUMMIT BASIC CEMENTED SZ 4; MODULAR CATHCART BALL 47MM OD; SUMMIT BASIC CEMENTED SZ 4
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 81