MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-02-120
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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
It was reported that the surgeon wants this size six std summit duofix measured and reported back to him if it was within tolerances.He broached to a size six but when he went to implant the stem it was 5 mm proud.He then tried to use threaded inserter and it cross threaded.Had to use a clamp on style also hammer which damaged the taper.A second size six standard was then opened after re broaching.It was implanted with out further problems.
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.H10 additional narrative: added: b5 and d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3 and h6 (clinical and impact code).
Event or Problem Description
Additional information was received stating that no adverse events occurred.Patient is doing well i was told.Surgeon does want to know if that implant was within size tolerances.Only one stem inserted was damaged trying to remove the stem.The taper was damaged because a clamp on slap hammer was used to remove the stem.
Event or Problem Description
Additional information received indicated that there was a ten-minute surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > examination of the returned stem is unable to determine a root cause for the problem experienced.Related dimensional inspection finds no discrepancy from drawing requirements.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.Device history lot = > a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review = > a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H10 additional narrative: added: b5 corrected: h3, h6 (clinical and impact codes), h8.

• Brand Name: SUMMIT DUOFIX TAP SZ6 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10975608
• Report Number: 1818910-2020-26558
• Device Sequence Number: 4330231
• Product Code: LPH
• UDI-Device Identifier: 10603295059479
• UDI-Public: 10603295059479
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2020

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 Model Number: 1570-02-120
• Device Catalogue Number: 157002120
• Device Lot Number: 9587069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020; 01/12/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 12/21/2020; 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR