MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CANCELLOUS BONE SCREW 6.5X25MM; BONE SCREWS AND PINS : SCREWS

Catalog Number	117225000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	08/13/2019
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 be filed as appropriate.
Event or Problem Description
The primary surgery was performed via tha (date of surgery was unknown).It was reported that the revision surgery was performed on (b)(6) 2019 by replacing the cup (p/n: 124552000), the liner (p/n: 123912500), the head (p/n: 152190052) due to loosening of the cup caused by wear of the liner, extensive osteolysis on the patient¿s right acetabular side.However, there was no loosening of the aml stem nor no trunionosis.Thus, the cup, the liner, 2 screws (p/ns: 117225000, 117230000) were explanted, a cemented cup was inserted after transplanted bone to acetabulum, the head was replaced without the aml stem was explanted.The surgery was completed without problem, and it was unknown whether there was a surgical delay or not.No further information is available.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CANCELLOUS BONE SCREW 6.5X25MM
• 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: 8951732
• Report Number: 1818910-2019-102739
• Device Sequence Number: 2472046
• Product Code: HWC
• UDI-Device Identifier: 10603295007616
• UDI-Public: 10603295007616
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 117225000
• Device Lot Number: XJ8DS4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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 22.225MM +0 (152190052/1172552).
• Outcome Attributed to Adverse Event: Required Intervention