MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +5; HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

Model Number 1363-12-000

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Health effect - clinical code: (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

The patient was revised due to infection.Doi: (b)(6) 2021.Dor: (b)(6) 2021.(left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to material, manufacturing, inspection or sterile processing contained in the manufacturing records that would contribute to the reported event.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing 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 +5
• 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: 12384160
• MDR Text Key: 268680749
• Report Number: 1818910-2021-18876
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032687
• UDI-Public: 10603295032687
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1363-12-000
• Device Catalogue Number: 136312000
• Device Lot Number: JD4773
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR CATHCART BALL 42MM OD; TAPERED SPACER ARTICUL/EZE +5; MODULAR CATHCART BALL 42MM OD; TAPERED SPACER ARTICUL/EZE +5
• Patient Outcome(s): Required Intervention