MAUDE Adverse Event Report: DEPUY (IRELAND) 9616671 S-ROM*SLEEVE PRX ZTT, 18D-SML; HIP FEMORAL STEM/SLEEVE

Catalog Number 550523

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical report states patient suffered an intra operative bone fracture.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update rec'd 01/08/2016 - the patient's medical records were received.The medical records were reviewed for mdr reportability.According to the medical records, upon impacting the sleeve into the proximal femur a nondisplaced oblique crack in the anterior inferior aspect of the femoral neck occured, approximately 3 cm long.The crack was cabeled.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 01/27/2016.

Manufacturer Narrative

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.Medical records were reviewed.From a medical perspective, based on the information available, it is not likely the complaint is product related.The investigation can draw no conclusions with the information made available.Corrective action has not been indicated.Monitor via (b)(4).Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY (IRELAND) 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY (IRELAND) 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5335027
• MDR Text Key: 34674974
• Report Number: 1818910-2015-38215
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2015

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: 06/30/2019
• Device Catalogue Number: 550523
• Device Lot Number: 7943730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2016; 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 52