MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 HIP BA BIO 28MM 12/14 + 1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 9111121

Device Problems Material Disintegration (1177); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Inflammation (1932); Pain (1994); Joint Dislocation (2374)

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.Device was used for treatment, not diagnosis.

Event Description

It was reported the surgeon is ordering a patient specific duraloc option inlay and a femoral head because of wear.In the x-ray dislocation of the femoral head in the sense of increased pe wear was seen.Also, there was reportedly moderate groin pain probably caused by synovitis.The original left side procedure occurred on an unknown date in 2005.Reportedly a revision procedure is planned.

Manufacturer Narrative

Product complaint #(b)(4).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.  added: (device code).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).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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.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.

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.Corrected: device codes.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.Device history lot: a review of the manufacturing records for the ceramic head product, lot 1128606 was completed by the manufacturing site, with notification received that: "dhr review: product code 9111121, work order 1128606 was manufactured on 08th august 2003.30 parts were manufactured per specification and all raw materials met specification.Cofc review: certificate of conformance review for 4034987 and 403523, product code 9111121, work order 1128606 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 will be filed as appropriate.

• Brand Name: HIP BA BIO 28MM 12/14 + 1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8304464
• MDR Text Key: 135038018
• Report Number: 1818910-2019-83203
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9111121
• Device Lot Number: 1128606
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/07/2019; 03/22/2019; 04/18/2019; 05/02/2019
• Supplement Dates FDA Received: 02/12/2019; 03/22/2019; 05/01/2019; 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR