MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 16X240A; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1977-16-240
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Wrong packaging of the product.No additional information available.Procedure: hip arthroplasty.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : examination of the returned device confirmed the stem is poking through the packaging.The root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
Event or Problem Description
Additional information received states that there was no adverse consequences that affected the patient and no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: RECLAIM DISTAL TAPERED 16X240A
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10454836
• Report Number: 1818910-2020-18798
• Device Sequence Number: 4092544
• Product Code: KWA
• UDI-Device Identifier: 10603295077183
• UDI-Public: 10603295077183
• Combination Product (Y/N): N
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2020

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 Expiration Date: 03/31/2022
• Device Model Number: 1977-16-240
• Device Catalogue Number: 197716240
• Device Lot Number: 231187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 11/10/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/26/2020; 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1