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

Catalog Number 157012120

Device Problems Fracture (1260); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 01/01/2019

Event Type  malfunction  

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 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.

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
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> 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.

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
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9292938
• MDR Text Key: 187200107
• Report Number: 1818910-2019-114910
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060178
• UDI-Public: 10603295060178
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 157012120
• Device Lot Number: 728557
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1