MAUDE Adverse Event Report: DEPUY ORTHOPEDICS, INC. DEPUY REPLICA STEM WITH 36MM+1.5 COBALT ; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC POLYMER,CEMENTS OR NON-POROUS UNCE

Device Problem Corroded (1131)

Patient Problems Encephalopathy (1833); Fatigue (1849); Pain (1994); Swelling (2091); Blurred Vision (2137); Toxicity (2333); Osteolysis (2377); Shaking/Tremors (2515); Sleep Dysfunction (2517)

Event Date 04/18/2017

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2013, he received a right total hip arthroplasty.The implant was a stryker secur-fit v40 132 degree neck angle #8 stem, x3 40 mm id, 60 mm titanium, with 40 mm +4 cobalt chrome heat, and 2 cancellous screws.He also has a left hip replacement with a depuy replica stem with a 36 mm + 1.5 cobalt chrome head implanted on (b)(6) 2014.On (b)(6) 2017, this whole blood cobalt level was 7.6 mcg/l and urine cobalt level was 12 mcg/l.On (b)(6) 2017, his whole blood cobalt level was 6.8 mcg/l and urine cobalt level was 24.2 mcg/l.On (b)(6) 2017, his whole blood cobalt level was 5.2 mcg/l and urine cobalt level was 15.0 mcg/l.On (b)(6) 2017, cobalt level right hip joint fluid aspirate ws 1,000 mcg/l and chromium level was 56 mcg/l.Cobalt level of left hip joint fluid aspirate ws 4.2 mcg/l, and chromium level ws 4.8 mcg/l.The cobalt / chromium levels of the hip joint fluid aspirate confirmed that the right stryker hip was generating more metal than the left hip.Pt had cardiac valve replacement in 2009 followed by pacemaker implantation.He developed sleep apnea in 2008.Since then, he progressively developed fatigue.In 2017, rest tremor of the hands and blurry vision were also noted.In 2017, he noted intermittent swelling and pain in the right hip.Metal suppression ct scan off the pelvis and bilateral hips on (b)(6) 2017, notable for some residual cystic osteolysis of the left peri-acetabular area.He does have more artifact on average on the left side because of the chrome cobalt stem.Right side shows no significant fluid collection or soft tissue changes and no osteolysis of the prosthetic left hip has some cystic osteolysis about the central fixation screw of the cup, and he may have some ballooning of the lateral right hip capsule consistent with a pseudotumor.He began taking n-acetyl cystein around (b)(6) 2017 for cobalt chelation.This was only partially effective.Fdg pet brain with neuro q analysis showed a pt of hypometabolism compatible with early arthroplastic cobalt encephalopathy.On (b)(6) 2018, the right hip was revised.Revision involved exchange of the crco head and x3 poly for a delta option ceramic 36mm +4 hed nd a zimmer constrained liner cemented into existing shell.The old stem was sound and was in about 20 degrees of anteversion.The trunnion of the stem and the head bore showed gross corrosion and internal corrosion.The poly was in good repair.The posterior capsule was attenuated but salvageable, anterior capsule was moderately thickened but salvageable abduction tendons were only slightly affected and did not require repair and the trochanteric bursa was affected with attrition of the tensor fascia femoris at the greater trochanter.His right hip joint fluid cobalt level was 930 mcg/l and chromium level was 240 mcg/l.On (b)(6) 2020, about 2 years post revision of the right hip, his whole blood cobalt level is less than 0.5 mcg/l and his urine cobalt level is 0.5 mcg/l.He has retained the depuy mop hip on the left side with cocr parts.Fda safety report id# (b)(4).

• Brand Name: DEPUY REPLICA STEM WITH 36MM+1.5 COBALT
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC POLYMER,CEMENTS OR NON-POROUS UNCE
• Manufacturer (Section D): DEPUY ORTHOPEDICS, INC.
• MDR Report Key: 9739350
• MDR Text Key: 180783030
• Report Number: MW5093160
• Device Sequence Number: 2
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 76