MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 COCR HEAD 28MM +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Type of Reportable Event	Malfunction
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
The primary surgery was performed on an unknown date at (b)(6) hospital.The 1st revision surgery was performed on (b)(6) at (b)(6) hospital.When the 1st revision surgery, the surgeon performed great trochanter osteotomy and jointed with a great trochanter grip, however, there was a suspicion of joint failure.And, there was also suspicion of loosening of the cup, the patient had been under follow-up by the surgeon.It was reported that the patient had a pain in early (b)(6) 2020, and the surgeon confirmed the dislocation of the head from the stem¿s neck by x-ray.There was no cause of the dislocation like impact shock.The surgeon thought that the corrosion of neck trunnion point caused the dislocation.The patient cannot walk due to the dislocation.The surgeon planned 2nd revision surgery by replacing the head if he can have his desired implant, but if the implant cannot be engaged, he will continue follow-up for the patient because removing the stem causes an extensive invasive surgery for advanced old age patient as (b)(6) years.No further information is available.
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.Patient codes device revision or replacement and insufficient information are being corrected to no code available ((b)(4)) to capture absence of treatment since they were incorrectly submitted in the initial medwatch.

• Brand Name: 9/10 COCR HEAD 28MM +0
• 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: 10511628
• Report Number: 1818910-2020-19739
• Device Sequence Number: 19601450
• Product Code: JDI
• UDI-Device Identifier: 10603295276630
• UDI-Public: 10603295276630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1521-90-058
• Device Catalogue Number: 152190058
• Device Lot Number: 2172574
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: CANCELLOUS BONE SCREW 6.5X15MM; CANCELLOUS BONE SCREW 6.5X20MM; CANCELLOUS BONE SCREW 6.5X30MM; CANCELLOUS BONE SCREW 6.5X30MM; DURALOC 1200 SERIES 56MM OD; ENDURON NEUT 56 OR 68ODX28ID; SOLUTION A 8IN BOW 13.5 LT; UNK HIP LOCKING RING
• Patient Age: 83 YR