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

Catalog Number 157012120

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3: the initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.

Event Description

The patient stated that the patient recently had blood tests and mri on inspection of my dupuy 2008 asr hip install with cobalt at 8.6 and chromium at 1.6.My doc says these should be under 1.0 and by all accounts my metals in blood are at toxic levels.The patient have surgery reports confirming the hip type and model by depuy.The patient also have metallosis, dead or contaminated tissue and possible a pseudo tumor shown in mri.The patient's mass general hip revision specialist doc says that the patient needs a revision asap as it is leaching into the patient's tissue and blood.Rather than get attorneys involved what is the guidance and assistance by j&j moving forward seeing the urgency to get this out of the patient's body? the patient prefer to get assistance as opposed to a long drawn out battle in the legal world.The patient takes no meds and in good health otherwise.

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.H10 additional narrative: added: a1, a2, e1, e3 (initial reporter occupation: lawyer).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Update ad 06 may2024: updated event description: on (b)(6) 2008, patient underwent depuy asr xl acetabular system on left hip.On (b)(6) 2023, the patient noticed progressive problems with the left hip.On (b)(6) 2023, patient was treated and was ordered an mri and blood testing for metal levels.Lab results revealed that chromium levels were abnormally high.Mri revealed osteolysis within the greater trochanter of the left hip with moderate joint effusion extending into the greater trochanteric bursa with internal debris.The patient had functionally disabling pain status post left metal-on metal tha with elevated metal levels and abnormal mri consistent with adverse local tissue reactions.A revision tha was recommended and planned.On (b)(6) 2024, the patient underwent left total hip arthroplasty.Following the surgery, patient's cobalt and chromium levels remained abnormally high.During the revision surgery, a large amount of necrotic soft tissue surrounding the metal on- metal hip joint required debriding, and upon entering the joint there was extensive evidence of metal debris, metallic stained fluid and corrosion.An approximately 50% loss of abductor muscles was noted.The metal femoral head device was removed, the corroded trunnion was cleaned, a ceramic femoral head device was implanted onto the trunnion, and a polyethylene liner was inserted into the existing asr acetabular cup.The asr cup was left in place to reduce the morbidity involved with cup extraction.As a result of the asr failure, revision surgery, extensive metal debris, corrosion, tissue necrosis, abductor muscle loss, osteolysis, and cobalt and chromium poisoning, the patient has suffered severe and permanent physical and mental injuries.Doi: (b)(6) 2008.Dor: (b)(6) 2024.Left hip.

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 that 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.Corrected: d1, d2a,d4 (catalog), h6 medical device problem code.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary no device associated with this report was received for examination.Product description:- summit duofix tap sz6 hi off product code:- 157012120.Lot no:- be4b31000.Quantity of manufactured (b)(4).Date of manufacturing:- feb-2007 expiry date:- feb-2017 as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot product description:- summit duofix tap sz6 hi off product code:- 157012120.Lot no:- be4b31000.Quantity of manufactured:- (b)(4).Date of manufacturing:- feb-2007 expiry date:- feb-2017 device history review
=
> a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d10.

• Brand Name: SUMMIT DUOFIX TAP SZ6 HI OFF
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18142857
• MDR Text Key: 328195779
• Report Number: 1818910-2023-23326
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2023

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 Expiration Date: 02/06/2017
• Device Catalogue Number: 157012120
• Device Lot Number: BE4B31000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/29/2023; 05/06/2024; 05/22/2024
• Supplement Dates FDA Received: 12/07/2023; 05/14/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2007
• 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 +8; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 122 KG