MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUN REV OFFST STM ADPTR 4MM; KNEE STEMS

Model Number	1513-04-000
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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
After taking out a offset adapter from the box, the staff tried to unlock the nut for the positioning of the tibia.But that implant doesn't work at all.And then he decided to change the process.At first, he assembled the stem with offset adapter.Second, he tried to change the offset but the offset adapter was still locked and the stem was also locked as well.Unfortunately, he took out the new implant.Surgical delay of 20 minutes.Replacement with new implant,.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The investigation could not draw any conclusions about the reported event.All available photographs were reviewed.Based on the photo evidence provided, complaint is not confirmed.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 : mre review: a manufacturing record evaluation was performed for the finished device number; and no non conformance was found during the review.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not draw any conclusions about the reported event.All available photographs were reviewed.Based on the photo evidence provided, complaint is not confirmed.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 = > mre review: a manufacturing record evaluation was performed for the finished device number; and no non conformance was found during the review,the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUN REV OFFST STM ADPTR 4MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12334180
• Report Number: 1818910-2021-18039
• Device Sequence Number: 20078845
• Product Code: JWH
• UDI-Device Identifier: 10603295475132
• UDI-Public: 10603295475132
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2021

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 Model Number: 1513-04-000
• Device Catalogue Number: 151304000
• Device Lot Number: 9609154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/07/2021; 10/21/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/08/2021; 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUN REV OFFST STM ADPTR 4MM; ATUN PRESSFIT STR STEM10X110MM