MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S; HIP COMPONENT

Model Number	PHA04402
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.It was indicated that this patient was revised due to aseptic stem loosening, adverse reaction to particulate debris, and a head/socket mismatch.The revised products were not returned for investigation.No radiographs, operative notes, or clinically relevant documentation was provided to confirm the complaint.Review of the device history record for this lot indicates that this product met all acceptance criteria at the time of manufacturing.This patient has a biolox delta ceramic femoral head articulating with a biolox alumina ceramic acetabular liner, which was stated to have been a mismatch.These products are the appropriate sizes, and even though the ceramic bearings are different models of ceramic, these products are indicated for use with each other as stated in the package insert for these products (150803-8).There is no information to assess the alleged tissue reaction due to wear debris.The microport hip systems package insert (150803-8) lists "dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity" as possible adverse effects of total hip arthroplasty.It also lists, "allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval)." there were no trends identified per mpo trending procedures.No further conclusions can be made regarding this event.This issue will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly, patient was revised due to loosening stem.Head/socket mismatch.Adverse soft tissue reaction to particulate debris.(b)(4).Side:l; primary asa: p2 - mild disease not incapacitating.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12132685
• Report Number: 3010536692-2021-00366
• Device Sequence Number: 4765475
• Product Code: LZO
• UDI-Device Identifier: M684PHA044021
• UDI-Public: M684PHA044021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: PHA04402
• Device Catalogue Number: PHA04402
• Device Lot Number: X10453674
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention