MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-228
Medical Device Problem Codes	Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Inadequate Osseointegration (2646)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
The following was reported: i had tha revision surgery in 2018.The stem was replaced with a stryker restoration modular one.The 28 mm ceramic femoral head was replaced with a cocr head.Hip, groin, and thigh pain continued.In 2019, i was diagnosed with a stress fracture at the tip of the prosthetic stem.In 2020, i had a bone graft to repair the fracture.A cloudy milky yellow fluid along with metal debris was discovered in the hip joint.Also, there was osteolysis in the proximal femoral femur.The acetabular had overhanging scar tissue and bone.The trunion had stripe wear indicating impingement and likely source of the metallosis.The 28 mm femoral head was replaced with a 40mm cocr head.Symptoms of metallosis continue.Update: as per the patient, he had a left tha on (b)(6) 2016.He started to experience pain at the end of (b)(6) 2016.The patient had a bone scan done on (b)(6) 2017 (approx.) which indicated infection/implant loosening.No treatment was given to the patient.On (b)(6) 2017 (approx.) he was placed on oral antibiotics for 30 days due to infection.On (b)(6) 2017 x-rays confirmed loosening and the patient was revised on (b)(6) 2018.Patient continued to experience pain after revision.A bone scan done on (b)(6) 2019 showed a fracture.The patient was placed on an 8 week of no leg bearing with bone stimulator.The patient was revised on (b)(6) 2020.Patient is still experiencing pain.He was given a cortisone injection in (b)(6) 2020 (approx.).The patient had 2 hip aspirations done on (b)(6) 2017 & (b)(6) 2017 (approx.) and 4 cortisone injections, 3 were done after surgery in 2018 and 1 in (b)(6) 2020 (approx).The patient (would like to know if implants are part of a recall.This pi is for revision of primary.Update as per email from patient: "the procedure is called iontophoresis.It's a method of delivering drugs through the skin using voltage gradients.It was delivered by a physical therapist.It was in the (b)(6) 2017 time frame.It put 1/4" round x 3/8" deep holes in my leg above the prosthesis.1st bone scan (b)(6) 2017 discovered loose prosthesis and possible infection.2nd bone scan (b)(6) 2019 due diligence before release.Discovered periprosthetic fracture.3nd bone scan (b)(6) 2019 confirmed that fracture did not heal with no weight bearing and bone growth stimulator for 8 weeks.I took the antibiotics between (b)(6) - (b)(6) 2017 to treat the assumed infection.1st hip aspiration on (b)(6) 2017 synovasure test positive for pjt.2nd hip aspiration at (b)(6) 2018 synovasure test positive for pjt.First saw doctor on (b)(6) 2017".
Event or Problem Description
The following was reported: i had tha revision surgery in 2018.The stem was replaced with a stryker restoration modular one.The 28 mm ceramic femoral head was replaced with a cocr head.Hip, groin, and thigh pain continued.In 2019, i was diagnosed with a stress fracture at the tip of the prosthetic stem.In 2020, i had a bone graft to repair the fracture.A cloudy milky yellow fluid along with metal debris was discovered in the hip joint.Also, there was osteolysis in the proximal femoral femur.The acetabular had overhanging scar tissue and bone.The trunion had stripe wear indicating impingement and likely source of the metallosis.The 28 mm femoral head was replaced with a 40mm cocr head.Symptoms of metallosis continue.Update: as per the patient, he had a left tha on (b)(6) 2016.He started to experience pain at the end on (b)(6) 2016.The patient had a bone scan done on (b)(6) 2017 (approx.) which indicated infection/implant loosening.No treatment was given to the patient.On (b)(6) 2017 (approx.) he was placed on oral antibiotics for 30 days due to infection.On (b)(6) 2017 x-rays confirmed loosening and the patient was revised on (b)(6) 2018.Patient continued to experience pain after revision.A bone scan done on (b)(6) 2019 showed a fracture.The patient was placed on an 8 week of no leg bearing with bone stimulator.The patient was revised on (b)(6) 2020.Patient is still experiencing pain.He was given a cortisone injection on (b)(6) 2020 (approx.).The patient had 2 hip aspirations done on (b)(6) 2017 (approx.) and 4 cortisone injections, 3 were done after surgery in 2018 and 1 on (b)(6) 2020 (approx).The patient (would like to know if implants are part of a recall.This pi is for revision of primary.Update as per email from patient: "the procedure is called iontophoresis.It's a method of delivering drugs through the skin using voltage gradients.It was delivered by a physical therapist.It was on (b)(6) 2017 time frame.It put 1/4" round x 3/8" deep holes in my leg above the prosthesis.1st bone scan on (b)(6) 2017, discovered loose prosthesis and possible infection 2nd bone scan on (b)(6) 2019, due diligence before release.Discovered periprosthetic fracture.3nd bone scan on (b)(6) 2019, confirmed that fracture did not heal with no weight bearing and bone growth stimulator for 8 weeks i took the antibiotics between on (b)(6) 2017 to treat the assumed infection.1st hip aspiration on (b)(6) 2017 synovasure test positive for pjt.2nd hip aspiration on (b)(6) 2018 synovasure test positive for pjt.First saw doctor on (b)(6) 2017".
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a ceramic head was reported.The event was confirmed via medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: ¿when seen in follow-up on (b)(6) 2017, due to the findings a hip aspiration was ordered for culture and alpha-defesin.The work-up showed a positive synovasure, but only wbc 1665 (40% poly).It was noted he had a positive nasal swab for staph.And had a try course of antibiotics for a month ¿septra due to mrsa history¿ then consider re-aspiration and see dr gersovich for an option.The patient was taken back to the operating room on (b)(6) 2018 for spacer vs complete revision.In the report the surgeon stated that there was evidence of loosening by x-ray and bone scan the stem explored.It appeared well fixed medial and lateral but had little bone anterior or posterior.¿ this was a very problematic case and history.The patient underwent total hip arthroplasty (tha) after orif for a hip fracture and ongoing pain.The speed to or, mild severity of the avascular necrosis (avn) and ongoing compensation claim complicated the case.The primary tha initially appeared effective but rapidly regressed.Revision surgery was performed without very clear indication preoperatively and intra-operatively.The revision surgery initially appeared effective then regressed.A stress fracture was identified leading to another surgery.At the surgery impingement was noted and the liner changed to a polyethylene.Again, initially the procedure appeared effective than rapidly regressed.The patient remains painful and was deemed to have reached maximal medical recovery orthopedically.There were no issues that appeared related to the implants.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 03-oct-2013 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: medical review of the provided records revealed that "this was a very problematic case and history.Revision surgery was performed without very clear indication preoperatively and intra-operatively." "there were no issues that appeared related to the implants." a microbiological assessment indicated that "due to the nature of the organisms isolated ¿ susceptible to various modes of sterilisation - and specifically the sterilisation methodology employed by stryker, it is not probable that staphylococcus species could have originated from the implants." all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10-6 in accordance to applicable iso standards.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.It was reported that the customer was inquiring if the reported device is subject to a recall.Based on the review, the reported product has not been involved in any recall.

• Brand Name: DELTA V-40 CERAMIC HEAD 28/+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10641224
• Report Number: 0002249697-2020-02062
• Device Sequence Number: 11593545
• Product Code: JDI
• UDI-Device Identifier: 04546540608529
• UDI-Public: 04546540608529
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 6570-0-228
• Device Catalogue Number: 6570-0-228
• Device Lot Number: 45509402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention