MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 BIOSTOP G CEM RESTR 12MM; CEMENT / CEMENT ACCESSORY

Catalog Number 546312000

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 08/19/2014

Event Type  Injury  

Event Description

Revision: shoulder arthroplasty performed on (b)(6) 2014 at (b)(6).Reason: glenoid prosthesis loosening.Primary: performed in (b)(6) 2004 at (b)(6).Explants - pegged glenoid prosthesis, further info tba.Implants; glenoid head - 113787025 lot 148841?, excentric head 52 x 21 -112852120 lot d13120041? pt details: (b)(6) yrs.Photos, reports available.(b)(6) 2014 - email received from (b)(6) conforming the following additional information from the surgeon - the surgeon did indicate during the case that as the glenoid and humeral head showed no signs of wear, reason for the revision was a case of cement failure as opposed to implant failure.Cement confirmed as depuy cement.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional narrative: this product was originally reported in error.Depuy considers the investigation closed at this time.

• Brand Name: BIOSTOP G CEM RESTR 12MM
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4050842
• MDR Text Key: 4906136
• Report Number: 1818910-2014-26978
• Device Sequence Number: 1
• Product Code: JDK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK943727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 546312000
• Device Lot Number: 03A2801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 75 YR