MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SCREW,6.5MM DIA,20MM LG; BONE SCREWS AND PINS : SCREWS

Catalog Number	556071
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
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 (b)(6) 2007 by using aml, pinnacle via tha.It was reported that the patient visited the hospital to complain that felt something wrong with her hip joint and felt the range of motion was also worse than before.Thus, the revision surgery was performed on (b)(6) 2019 by replacing the metal liner (p/n: 121889150) to a poly liner, the head (p/n: unknown) to a delta ceramic head.The surgeon explanted the metal liner, crushed artificial bones with a bone mill, transplanted to the acetabular holes, and tightened a screw (p/n: unknown) of a cup which was loose and inserted one additional screw.The surgery was completed without a surgical delay.The surgeon considered that there was some bone reaction, however it was unlikely to be the effect of metal on metal.The patient had no pain and no problem with blood reaction.No further information is available.
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 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search did find a previous complaint for the head lot (dint 11780) but that was a metal on metal issue which has been discounted by the surgeon in this case due to no pain and no problem with blood reaction.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, a follow-up medwatch will be filed as appropriate.

• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8739601
• Report Number: 1818910-2019-96939
• Device Sequence Number: 2534785
• Product Code: LPH
• UDI-Device Identifier: 10603295175919
• UDI-Public: 10603295175919
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 06/06/2019

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: 556071
• Device Lot Number: 307735R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 77