MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 47MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Model Number	1363-47-000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient had hemiarthroplasty performed (b)(6) 2020.Was brought back to or 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.
Additional 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: MODULAR CATHCART BALL 47MM OD
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10843170
• Report Number: 1818910-2020-24661
• Device Sequence Number: 3629455
• Product Code: LZY
• UDI-Device Identifier: 10603295032793
• UDI-Public: 10603295032793
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K903084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1363-47-000
• Device Catalogue Number: 136347000
• Device Lot Number: D20081073
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUMMIT BASIC CEMENTED SZ 4; TAPERED SPACER ARTICUL/EZE -3; SUMMIT BASIC CEMENTED SZ 4; TAPERED SPACER ARTICUL/EZE -3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 81