MAUDE Adverse Event Report: BIOMET UK LTD. TAPERLOC BMPC 13.5X147MM 12/14; HIP PROSTHESIS

Model Number N/A

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Inflammation (1932); Swelling/ Edema (4577)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported in a retrospective clinical study that preceding a total hip arthroplasty, infection and an abscess occurred four years¿ post-surgery.Chirurgical drainage without opening the joint capsule was required to resolve the complication.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical device(s): acet.Comp.Rloc spdrcp 52mm/23, item# 1047-52, lot# unknown; batcup arc 10#lr 32i/d t23 rnl, item# 1076-23, lot# unknown; ceramic alu head 12/14 32mm s, item# 1010-35, lot# unknown.Report source ¿ foreign ¿ spain.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Device remains implanted.

Event Description

It was reported in a retrospective clinical study that four years¿ post initial right total hip arthroplasty, the patient presented with a psoas abscess requiring incision and drainage of the site.From that procedure, cultures grew staphylococcus lugdunensis.The patient was treated with antibiotics and was followed by internal medicine and infectious disease.Subsequently, seven months later, the patient underwent another incision and drainage procedure.The joint space was not entered; therefore, no product was exchanged.The patient was further followed and treated by internal medicine.The patient showed improvement and was discharged without further known complications.All initial implants remain intact.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were provided and reviewed by a health care professional.Superficial infection 4 years post implantation attributed to an organism considered to be normal skin flora which proliferated into an abscess, treated with antibiotics and i&d, discharged due to clinical stability and declining inflammatory markers.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TAPERLOC BMPC 13.5X147MM 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16608078
• MDR Text Key: 311956614
• Report Number: 3002806535-2023-00054
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 05019279130771
• UDI-Public: (01)05019279130771
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0556BM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 74 KG