MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157012110

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Cyst(s) (1800); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Distress (2329); Injury (2348); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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

Pinnacle litigation received: litigation alleges severe and constant pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, metal toxicity, bone erosion and pseudotumors.It was also indicated that there was bursitis and emotional distress.The plaintiff seek compensatory damages.Doi: (b)(6) 2007; dor: not reported: left hip.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received.Pfs alleges injury and pain in hip when walking and standing.After the review of medical records for mdr reportability, radiographs reported benign cystic change at the left supra acetabular ilium, and tiny amount of fluid or synovitis.Metal ion levels are below 7 ppb.There were no implant nor revision notes provided.

Manufacturer Narrative

Udi: (b)(4).

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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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 DUOFIX TAP SZ5 HI 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: 7348111
• MDR Text Key: 102711460
• Report Number: 1818910-2018-55358
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157012110
• Device Lot Number: Z87CY1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 04/27/2018; 04/27/2018; 03/27/2018; 12/26/2018; 07/17/2019
• Supplement Dates FDA Received: 04/04/2018; 04/06/2018; 04/06/2018; 04/09/2018; 01/04/2019; 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention