MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-080

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Physical Asymmetry (4573)

Event Date 04/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr medical records received.After review of medical records the patient was revised to address pain and elevated metal ions.Operative note reported efflux of grayish thin fluid, soft tissue metallosis, 1 cm area of spot weld noted without any ingrowth and limb asymmetry.Doi: (b)(6) 2009; 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 # (b)(4).Investigation summary : 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.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 : 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 will be filed as appropriate.

Event Description

Pfs alleges metallosis, blood toxicity, walking and standing difficulty, depression, hair loss, memory loss, problems with balance, and discomfort.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ2 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9588375
• MDR Text Key: 175856435
• Report Number: 1818910-2020-01816
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295059332
• UDI-Public: 10603295059332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170339
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

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 Model Number: 1570-01-080
• Device Catalogue Number: 157001080
• Device Lot Number: CG9FE1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 02/12/2020; 02/23/2023
• Supplement Dates FDA Received: 02/17/2020; 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR 300 SPIKED CUP SIZE 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ2 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female