MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Visual Disturbances (2140); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 04/18/2017

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

He received a right 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 a 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 2014.On 2017, this whole blood cobalt level was 7.6 mcg/l and urine cobalt level was 12 mcg/l on 2017.His whole blood cobalt level was 6.8 mcg/l and urine cobalt level was 24.2 mcg/l on 2017.His whole cobalt level was 5.2 mcg/l and urine cobalt level was 15.0 mcg/l.On 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/chroium levels of the hip joint fluid aspirate confirmed that the right stryker hip was generating more metal than the left hip.Patient 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 a 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 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 pseudotumor.He began taking n-acetyl cystein around 2017 for cobalt chelation.This was only partially effective.Fdg pet brain with euro q analysis showed a patient of hypometabolism compatible with early arthroplastic cobalt encephalopathy.On 2018, the right hip was revised.Revision involved exchange of the crco head and x3 poly for the delta option ceramic 36 mm + 4 head and 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 and the trochanteric bulsa was affected with attrition of the tensor fascia femoris at the greater trocahnter.His right hip joint fluid cobalt level was 930 mcg/l and chromium level was 240 mcg/l.On 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.

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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9915844
• MDR Text Key: 189842611
• Report Number: 1818910-2020-09989
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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 Catalogue Number: UNK HIP FEMORAL HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: HIP SCREW; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention