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 Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2021

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

The patient was revised to address loosening of the stem at the cement to implant interface.Cement manufacturer is unknown.Patient had an alval on the side of her hip leading the surgeon to believe that the hip prosthesis was having micromotion causing some metal wear.Originally implants were a cobalt chrome summit cemented stem with a cobalt chrome spacer and monopolar hemi arthroplasty head.She was revised to a total hip with a pinnacle cup, altrx liner, screw, corail revision, and delta ceramic head.Lack of metalosys in joint but raised ion levels pre op.Doi: (b)(6) 2018, dor: (b)(6) 2021, affected side: unknown hip.

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 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: 12513546
• MDR Text Key: 272746717
• Report Number: 1818910-2021-20778
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1363-12-000
• Device Catalogue Number: 136312000
• Device Lot Number: HP9952
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEMENTRALIZER 8.5MM; MODULAR CATHCART BALL 44MM OD; SUMMIT CEMENTED STEM SZ2 STD; TAPERED SPACER ARTICUL/EZE +5; CEMENTRALIZER 8.5MM; MODULAR CATHCART BALL 44MM OD; SUMMIT CEMENTED STEM SZ2 STD; TAPERED SPACER ARTICUL/EZE +5
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80