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

Model Number	1172-25-000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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 (b)(6) 2004 via tha by using the cup (p/n: 960013000), the liner (p/n: 960019000), the stem (p/n: 900531210) with the sleeve (p/n: 521465), the head (p/n: 152190051).It was reported that the revision surgery was scheduled to be performed on (b)(6) 2020 by replacing the cup due to loosening acetabular side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial contact is a health professional, not a lawyer.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 patient code: no code available (3191) used to capture device revision or replacement.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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. .
Event or Problem Description
Additional information received indicating: the patient has had hip osteotomy in the past, the primary surgery was performed on (b)(6) 2004 via tha for the right hip joint.Since the acetabular wear was remarkable, the revision surgery was performed as scheduled.All implants on the acetabular side were explanted, allograft, artificial bone and metal mesh were transplanted, a cemented cup was fixed.The stem was retained.The poly liner was worn out enough to be visually recognized by x-ray.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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: 9647807
• Report Number: 1818910-2020-03601
• Device Sequence Number: 3414132
• 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 Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1172-25-000
• Device Catalogue Number: 117225000
• Device Lot Number: YT3D14000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/17/2020; 01/28/2020; 02/27/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 01/30/2020; 02/24/2020; 03/04/2020
• 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 22.225MM -3; CANCELLOUS BONE SCREW 6.5X20MM; J-LOC 1200 SERIES 42MM OD; J-LOC 42MM X 22.225MM ID NEUT; S-ROM*SLEEVE PRX ZTT, 16B-LRG; SROM 9/10 16X11X130 30
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR