MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HARDINGE FEM CEMENT RESTR; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Catalog Number 963203000

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/14/2018

Event Type  Injury  

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.

Manufacturer Narrative

Product complaint # (b)(4).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 Description

Claim letter received alleging pain, inability to walk without crutches, inability to move, trouble sleeping, spasms, discomfort, suffering, significant loss of amenity.Doi: (b)(6) 2017 - dor: (b)(6) 2018 (right hip).Email notification from (b)(6) received alleging infection.Primary surgery date has been updated to (b)(6) 2015 and revision date (b)(6) 2016.The revision on (b)(6) 2017 noted on the (b)(6) appendix b matches with the second stage revision mentioned on the original claim letter.It was indicated that during this date, the infection had settled and the client's hip was now put back in place.It is unknown if the definitive implants are from depuy.It should be noted that around ten days after the definitives were implanted, the patient had experienced pain again.It was also indicated that this claim is not actively litigated.Doi: (b)(6) 2015 - dor: (b)(6) 2016 (right hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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 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.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.

• Brand Name: HARDINGE FEM CEMENT RESTR
• Type of Device: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9769544
• MDR Text Key: 185429986
• Report Number: 1818910-2020-06334
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 963203000
• Device Lot Number: D16072495
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 05801441/G6106999; 63642136/G6166311; 66017569/84294526; 66017569/85294526
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR