MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ8 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157001150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Test Result (2695)

Event Date 06/07/2011

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.

Event Description

Pinnacle ppf, sticker sheets and implant records received.Ppf alleges open and closed dislocation, constrained liner and elevated metal ions after first revision.Doi: (b)(6) 2010; dor: (b)(6) 2011; (left hip).

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.Product complaint #
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> (b)(4).Investigation summary
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> no device associated with this report was received for examination.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
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> a6aeb1000.Device history batch
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> null.Device history review
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> dhr for part number 157001150 batch number a6aeb1 was reviewed.There was a hold ticket for foreign material on the part, but rework steps were added to meet the product specifications.No other deviations or anomalies were observed.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.

• Brand Name: SUMMIT POR TAPER SZ8 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8407568
• MDR Text Key: 138366122
• Report Number: 1818910-2019-86860
• Device Sequence Number: 1
• Product Code: LHP
• UDI-Device Identifier: 10603295059394
• UDI-Public: 10603295059394
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/13/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157001150
• Device Lot Number: A6AEB1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR