MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-12-090

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Headache (1880); Hearing Impairment (1881); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Seizures (2063); Tissue Damage (2104); Visual Impairment (2138); Burning Sensation (2146); Cramp(s) (2193); Dizziness (2194); Injury (2348); Hypoesthesia (2352); Depression (2361); Shaking/Tremors (2515); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 12/18/2012

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

Ppf alleges metallosis, metal wear and elevated metal ions.Doi: (b)(6) 2006 - dor: (b)(6) 2012 (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
=
> the device associated with this report was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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).The device associated with this report was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

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.   udi: (b)(4).Patient code: no code available ((b)(4)) used to capture the blood heavy metal increased, device revision or replacement, tendon injury, heart injury, paresthesia, balance disorder, sensory loss, soft tissue injury, and surgery prolonged.

Event Description

Pfs and medical records received.Pfs alleges multiple significant and persistent injuries, defective implants, metallosis, noise, loosening, stem twist inside the femur, pain, muscle cramps, tendon pain, difficulty standing, walking, sitting and engaging in basic daily activities, dizziness, severe headache, general malaise, depression, rashes, skin irritations, constant irritability, insomnia, problem with eyesight, hearing, and general cognition, difficulty comprehending even basic information, tracking conversations and remembering or focusing on a particular subject matter, significant heart problems, including left ventricular hypertrophy and cardiomyopathy, tremor, grand mal seizures, increasingly and severely unstable, fatigued, instability, poor balance, fall, injuries to eye, nose, head, fractured wrist, burning, tinging, numbness in extremities, constant and significant confusion, and thoughts of suicide.After review of medical records, patient was revised to address failed left total hip arthroplasty.Revision notes stated that a defect and detachment of the short external rotator was noted when the it band was incised along the skin incision.A significant amount of metallosis with blackening of the soft tissue was encountered.A very thin femoral shell present proximally.The metallosis had caused a cavity to be present about the proximal 1/3 of the femur.Only a thin femoral shell was intact.As the implant was freed from the proximal femur, the femoral bone was found to fatigue and fail.Significant comminution occurred as a result of her poor bone stock.Further down the shaft, the cortical bone was thicker.The implant was freed with little difficulty.The femoral implant, after a significant amount of time and difficulty, was removed from the native femur.The acetabulum was thought to be loose, but was found to be not completely free.Peripherally, again it was noted there was very poor native bone stock.It appeared a fiber union present above the acetabulum.Significant metallosis was found to be present in pockets above the anterior aspect of the hip.All metallosis was removed from the hip.

Manufacturer Narrative

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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT DUOFIX TAP SZ3 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8109872
• MDR Text Key: 128562400
• Report Number: 1818910-2018-76413
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060147
• UDI-Public: 10603295060147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011489
• 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,Followup
• Report Date: 03/18/2020

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: 1570-12-090
• Device Catalogue Number: 157012090
• Device Lot Number: Z88DT1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 09/26/2019; 09/26/2019; 03/18/2020; 02/15/2022
• Supplement Dates FDA Received: 09/29/2019; 10/15/2019; 04/08/2020; 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 63 KG