MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

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 Description

Literature article entitled, ¿lessons learned from early clinical experience and results of 300 asr hip resurfacing implantations¿ by t siebel, s maubach, and m m murlock published by journal of engineering in medicine proc.Imeche vol.220 part pages 345-353 was reviewed for mdr reportability.The article assesses early clinical results of new fourth-generation resurfacing hip replacements based upon 300 asr resurfacing implant cases (108 female and 192 males between 18-76 years old) between august 2003 and april 2005 with a follow time average of 202 days.The article reports 8 revisions consisting of 5 femoral neck fractures (four male and one female), 1 malpositioned cup, 1 for luxation (non-compliant patient with parkinson¿s disease) leading to surgical replacement of acetabular cup in maximal anteversion, and 1 for persistent post-operative pain that led to synovectomy.All femoral neck fracture revisions entailed leaving acetabular cup in place and femoral neck resection with conventional stem with asr xl revision head.The article makes note that one femoral fracture case reveals incomplete seating of the femoral component by post-operative x-ray.The article notes that ¿the major reasons for revision surgery were apparently caused by technical implantation errors and patient selection.¿ the article mentions 1 specific case by identifying age and sex of patient and is reported in a linked pc.Patient harms reported: pain, revision, femoral neck fracture, dislocation.Product related events: malpositioning, dislocation.

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 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.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.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8797692
• MDR Text Key: 151278942
• Report Number: 1818910-2019-98520
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention