MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNIVERSAL STEM 115X20MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	867433
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: evaluation of the returned device and packaging components confirms the reported event.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.Device history lot: product code 867433, lot number dl1s54000.Device history review: no anomalies noted and all packaging conforms to all process and product specification requirements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The 115x20mm stem was opened and the inner packaging was stained - the second sterile pouch was also stained and the surgeon was unsure of the implant sterility and could not use this.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: evaluation of the returned device and packaging components confirms the reported event.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.Device history lot: product code 867433, lot number dl1s54000.Device history review: no anomalies noted and all packaging conforms to all process and product specification requirements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL STEM 115X20MM FLUTED
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8188899
• Report Number: 1818910-2018-78952
• Device Sequence Number: 16710987
• Product Code: JWH
• UDI-Device Identifier: 10603295217930
• UDI-Public: 10603295217930
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 867433
• Device Lot Number: DL1S54000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 79