MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 801037 FCS CERAMIC 54 OR 56X28; DURALOC OPTION IMPLANTS : HIP CERAMIC ACETABULAR LINERS

Catalog Number 159963054

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Tissue Damage (2104); Fibrosis (3167); Not Applicable (3189)

Event Date 01/01/2018

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.

Event Description

Revision due to soft tissue injury, instability, implant fracture, noise, and dislocation.

Manufacturer Narrative

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.Corrective action was not indicated.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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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: the devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present 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: product code 159963054, lot number 1160577 was manufactured on dec 2003.(b)(4) parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.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: FCS CERAMIC 54 OR 56X28
• Type of Device: DURALOC OPTION IMPLANTS : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 801037; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7905987
• MDR Text Key: 121600708
• Report Number: 1818910-2018-70382
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P040023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2008
• Device Catalogue Number: 159963054
• Device Lot Number: 1160577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 10/02/2018; 03/26/2019; 05/29/2019
• Supplement Dates FDA Received: 10/24/2018; 04/15/2019; 06/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR