MAUDE Adverse Event Report: BIOMET, INC. 52MM MALLORY SHELL WITH A 38MM COBALT CHROME LINER AND 38MM COBALT CHROME HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYER, POROUS UNCEMENTED

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Chills (2191); Toxicity (2333); Sweating (2444); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

Pt: (b)(6); on (b)(6) 2003, the pt received a right tha from dr (b)(6) at (b)(6) university med ctr.It was a biomet implant with a 52mm mallory shell with a 38/mm cobalt chrome liner and a 38mm cobalt chrome head on a mallory stem.On (b)(6) 2019, he was seen at the emergency dept for right leg pain that had been progressive over the past four months, suggesting the problem began in (b)(6) of 2019.He was diagnosed by dr (b)(6) in the er as having symptoms of metallosis relating to the right artificial hip.The pain was described as a once vague but now severe pain that is notable with standing or sitting up.He had no pain without weightbearing.He also noted progressive development of night sweats, which began as occasional incidents and by the time he went to the er was occurring frequently and he was soaking his sheets at night.During the day, he experienced shaking chills.Prior imaging studies of the hip and were negative for any problems.He had been seen multiple times at another hosp and clinic prior to receiving a diagnosis at this er visit.The hip was aspirated and was found to have an inflammatory infiltrate without apparent bacterial growth, thought to be consistent with an adverse reaction to metal debris.On (b)(6) 2019, dr (b)(6) revised the right hip due to metallosis.He performed a modular revision, exchanging the chrome cobalt head for a dual mobility construct involving a 38mm outer g7 head with a 28mm inner ceramic head with a +6 titanium sleeve adaptor.There was metal-stained tissue and while milky fluid.The milky fluid yielded a negative gram stain.On (b)(6) 2019, he was taken back to the operating room for incision and debridement for continued wound dehiscence.The wound continued to drain despite this i&d, and he was referred to see dr (b)(6) on (b)(6) 2019 for a second opinion.He had persistently draining right hip.Due to concern of development of deep infection the right tha was revised again on (b)(6) 2019.The revision involved removal of the acetabular construct and the femoral head, the stem was retained but thoroughly scrubbed.The new implants involved a stryker trident multiple hole socket, a zimmer constrained liner with 32mm id was cemented into the socket using antibiotic-loaded cement, and the head was replaced with a 32mm biolox delta option ceramic head with a +0 neck length.Tissue sample from the hip capsule grew rare staph epidermis a.He was discharged with an aquacel dressing over the wound and an antibiotics regimen involving intravenous vancomycin 1g twice daily for 6 weeks, transition to oral keflex for next 6 weeks, and oral rifampin for 12 weeks.Hip aspirate had a cobalt level of 2.7 ppb.Fda safety report id# (b)(4).

• Brand Name: 52MM MALLORY SHELL WITH A 38MM COBALT CHROME LINER AND 38MM COBALT CHROME HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYER, POROUS UNCEMENTED
• Manufacturer (Section D): BIOMET, INC.
• MDR Report Key: 9779724
• MDR Text Key: 182228478
• Report Number: MW5093476
• 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: 02/27/2020
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 79