MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER AML COCR STEM WITH SROM 28MM ID LINER, AND A 28MM COCR HEAD; PROSTHESIS HIP, SEMI-CONSTRAINED METAL/CERAMIC/POLYMER, CEMENTED

Device Problems Corroded (1131); Material Fragmentation (1261); Naturally Worn (2988)

Patient Problems Encephalopathy (1833); Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Pain (1994); Weakness (2145); Depression (2361); Shaking/Tremors (2515); Ambulation Difficulties (2544); Test Result (2695)

Event Type  Injury  

Event Description

Pt id: (b)(6).Her left hip was injured following a motor vehicle accident in 1986.The left total arthroplasty was performed around 2000 for post-traumatic arthritis.The implant was a zimmer aml cocr stem with srom 28mm id liner, and a 28mm cocr head; beginning around 2013, she developed progressive and limiting pain of the left hip.She was assessed for this hip pain on (b)(6) 2018, and notable findings were: left hip abductor and hip flexor weakness and pain and fullness of the left hip area.Metal suppression mri study of the left hip was done on (b)(6) 2018, and showed an intrapelvic mass at the medial wall that measures 5 cm in maximal diameter, another mass involving the lateral pelvic wall and another at the anterior superior extracapsular area measured 3.3 cm.These masses are pseudotumors that are typical in appearance for reaction to plastic wear.In 2014, she developed a fine rest tremor of both hands.In 2015, she developed issues with her mood and depression.She has significant back pain requiring narcotics.In (b)(6) of 2017, she started experiencing issues with her balance.She has peripheral neuropathy of both hands and feet.She has had multiple concussions from prior motor vehicle accidents.There was some concern of cobalt toxicity mixed with etiologies of prior neurological injury and spine condition.Neuro q analysis of fdg pet brain scan showed generalized and focal hypometabolism compatible with chronic toxic encephalopathy.On (b)(6) 2018, her urine cobalt level was 0.9 mcg/l and her blood cobalt level was 0.7 mcg/l.On (b)(6) 2018, the left tha was revised for pain, anterior pseudotumor, severe wear of polyethylene liner, elevated blood and urine cobalt levels and for symptoms of cobalt encephalopathy possibly corroborated by fdg pet brain scan showing hypometabolism.The new implant was a zimmer wagner 15mm, 190mm stem, zimmer cemented e-poly high-wall 36mm id liner, delta ceramic 36mm 0 length head, 3 luque wires and 50 cc local bone graft with 1g vancomycin.The superficial periprosthetic tissues were not inflamed.The trochanteric bursa was not effused.The capsule was thickened and typical fish-flesh fashion consistent with adverse reaction to metal debris.There was 4cm freely mobile solid mass anterior to the hip capsule that we elected not to excise due to concern of causing injury to the femoral nerve or vessel.The socket was well positioned and ingrown so it was not revised, the plastic was nearly completely worn through so it was revised.The stem was solidly fixed with some minor proximal lysis.The 16/14 trunnion of the stem showed evidence of corrosion.There was no external corrosion noted at the head-neck taper but internal corrosion is present.Left hip joint fluid was collect and believed to be diluted about 1:4 with local anesthetic, and the cobalt level of this diluted fluid was 15 mcg/l.Fda safety report id# (b)(4).

• Brand Name: ZIMMER AML COCR STEM WITH SROM 28MM ID LINER, AND A 28MM COCR HEAD
• Type of Device: PROSTHESIS HIP, SEMI-CONSTRAINED METAL/CERAMIC/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 9799924
• MDR Text Key: 182745233
• Report Number: MW5093558
• Device Sequence Number: 1
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 69