MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CANCELLOUS BONE SCREW 6.5X30MM; BONE SCREWS AND PINS : SCREWS

Model Number	1172-30-000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 (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).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.

• Brand Name: CANCELLOUS BONE SCREW 6.5X30MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10511545
• Report Number: 1818910-2020-19733
• Device Sequence Number: 3508146
• Product Code: HWC
• UDI-Device Identifier: 10603295007623
• UDI-Public: 10603295007623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970929
• 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: 1172-30-000
• Device Catalogue Number: 117230000
• Device Lot Number: Z6CEL4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• 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: 9/10 COCR HEAD 28MM +0; CANCELLOUS BONE SCREW 6.5X15MM; CANCELLOUS BONE SCREW 6.5X20MM; 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