MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER HERITAGE METAL ON PLASTIC HIP (COBALT CHROME STEM AND FEMORAL HEAD); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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

Patient Problems Arthritis (1723); Inflammation (1932); Pain (1994); Toxicity (2333); Arthralgia (2355); Osteolysis (2377)

Event Date 07/28/2018

Event Type  Injury  

Event Description

Pt id: (b)(6).On (b)(6) 2001.The patient underwent a left total hip arthroplasty.It was a zimmer heritage size 12 stem with standard offset and a 28 mm +3.5 chrome-cobalt head and non-lipped longevity polyethylene liner and trilogy socket.It had dislocated posterior superiorly and was reduced under anesthesia on (b)(6) 2001.The patient was in a hip spica cast for 3 weeks after that.In 2018, the patient began experiencing sharp activity-related right hip pain relating to the right hip osteoarthritis.The left prosthetic hip does not cause pain.A metal-suppression mri of the left hip was done on (b)(6) 2018, which was slightly obscured by some metal artifact.There appeared to be a bit of fluid collecting around the left hip replacement.She also had an area of high signal at the cement stem interface more distally, which could be early loosening of the stem at the cement mantle.There was no flagrant pseudotumor about the left hip, although there seemed to be a slight fluid collection.There was also a discrete area of osteolysis at the lateral shoulder of the hip prosthetic stem at the bone-cement interface.There was perhaps some osteolysis at the cement-stem interface more distally, which may be early loosening of the stem at the cement mantle.Joint fluid was collected from the left hip and believed to be diluted 1:20 and the cobalt level of this fluid was 160 mcg/l.The patient began experiencing what the patient terms as occasional senior moments.On (b)(6) 2018, the patient¿s urine cobalt level was 55.4 mcg/l.On (b)(6) 2018, the patient¿s blood cobalt level was 20.2 mcg/l.On (b)(6) 2018, the patient¿s urine cobalt level was 56.3 mcg/l.Neuro q analysis of her fdg pet brain scan was notable for focal and general hypometabolism suggestive of chronic toxic encephalopathy.The left hip was revised on (b)(6) 2018.Revision implant was a zimmer wagner sl 16mmx190mm stem with a delta ceramic 32mm +3.5 neck head a new longevity liner in the retained trilogy socket and the stem was fixed with 3 luque wires.The capsule was thickened and had the fish-flesh appearance typical of an armed.The posterior capsule was significantly attenuated and the anterior capsule was thickened and required debridement.The hip abductor tendons were attenuated and required repair with ethicbond.The stem was solidly fixed and there was marked black corrosion debris at the cement stem interface.There was minimal corrosion evident at the stem-head taper, there was proximal femoral bone deficiency due to extraction of the stem that was treated with grafting.Frozen section of left hip tissue collected during revision surgery was sent to pathology, which reported that the tissue had no features to suggest suppurative inflammation.On (b)(6) 2019, her cobalt levels were rechecked and found to be significantly lowered.Her blood cobalt level was 1.9 mcg/l and her urine cobalt level was 1.9 mcg/l and her urine cobalt level was 4.3 mcg/l.Fda safety report id # (b)(4).Fda received date: 01/31/2020.

• Brand Name: ZIMMER HERITAGE METAL ON PLASTIC HIP (COBALT CHROME STEM AND FEMORAL HEAD)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER, INC.; warsaw IN
• MDR Report Key: 9672115
• MDR Text Key: 178212677
• Report Number: MW5092775
• Device Sequence Number: 1
• Product Code: JDI
• 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: 01/31/2020

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2020
• 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: 77 YR
• Patient Weight: 62