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

Catalog Number	157012120
Medical Device Problem Codes	Fracture (1260); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2019
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
Size 6 hi summit was implanted and sat up.Dr.(b)(6) attempted to remove the stem to rebroach, but the threaded extractor would not thread into the stem.After several failed attempts, we had to use a vice grip and slap hammer to remove the stem.The neck of the implant was slightly damaged from this, so we had to open a new implant.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 10.Action taken when event occurred? opened new implant and extracted old one with vice grip.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.(b)(4).Device property of: none.Device in possession of: -->none.(b)(4).Device property of: hospital.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst: true.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot null.Device history batch null.Device history review null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The previous device code (fracture) is being retracted as it was further identified that the product is not fractured.

• Brand Name: SUMMIT DUOFIX TAP SZ6 HI 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: 9292938
• Report Number: 1818910-2019-114910
• Device Sequence Number: 16722183
• Product Code: LPH
• UDI-Device Identifier: 10603295060178
• UDI-Public: 10603295060178
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/14/2019

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: 157012120
• Device Lot Number: 728557
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/26/2019; 11/26/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 11/27/2019; 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1