MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 28MM -3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-057
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will b.
Event or Problem Description
This mdr is related to the fourth revision surgery on (b)(6) 2021.It was reported that on an unknown date, the patient underwent the tha surgery with unknown implants.On an unknown date, the loosening of the implant occurred, and the first revision surgery was performed.In the revision, zimmer biomet plate, zimmer biomet cup and solution plus stem (j&j product) were implanted.On (b)(6) 2017, the second revision surgery was performed due to the implants loosening at acetabular side.In the revision, zimmer biomet plate, zimmer biomet cup and the head (j&j product) were implanted.On (b)(6) 2020, the third revision surgery was performed due to the implants loosening at acetabular side.In the revision, zimmer biomet augment, zimmer biomet plate, zimmer biomet cup and the head (j&j product) were implanted.On (b)(6) 2021, the fourth revision surgery was performed due to the implants loosening at acetabular side.The surgeon commented that there is no looseness in the connection part, but there may be an effect of trunionosis in the connection part between the neck and head.In the revision, zimmer biomet augment, zimmer biomet cup and the head (j&j product) were implanted.The surgery was completed successfully without any surgical delay.No further information is available.
Additional 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 related reported incidents against the provided product code/lot number combination since release for distribution.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: 9/10 COCR HEAD 28MM -3
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12106766
• Report Number: 1818910-2021-14213
• Device Sequence Number: 4580842
• Product Code: JDI
• UDI-Device Identifier: 10603295276623
• UDI-Public: 10603295276623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 1521-90-057
• Device Catalogue Number: 152190057
• Device Lot Number: D19031637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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: 9/10 COCR HEAD 28MM -3; COMPETITOR; COMPETITOR; UNKNOWN HIP FEMORAL STEM; 9/10 COCR HEAD 28MM -3; COMPETITOR; COMPETITOR; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 58