MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 30MM; HIP PROSTHESIS

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994); Tissue Damage (2104)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to unknown product location.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 51-107120, tprlc 133 mp type1 pps ho 12.0, 3863366; 12-115120, cer bioloxd mod hd 36mm -3 nk, 055620; 110017105, g7 finned 4 hole shell 56f, 3757306.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-07151, 0001825034-2018-07152, 0001825034-2018-07154.

Event Description

It was reported patient underwent total hip arthroplasty and presented at 7.5 months post operatively with worsening pain in the right hip.Workup revealed inflammatory markers.Aspiration revealed periprosthetic joint infection with methicillin-sensitive staphylococcus epidermidis.Patient underwent 2 stage exchange including radical debridement and delayed reimplantation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi: (b)(4).Reported event was confirmed by review of operative notes.During the stage 1 revision patient was revised for pain and infection.During the surgery, purulent fluid was noted.The stem was noted to be well fixed while the acetabular cup was found to be loose.Nonviable tissue was debrided and cement spacer was implanted.During the stage 2 revision, patient was noted to have normalized inflammatory markers and well-healed wound.Cement spacer was removed and devices were reimplanted.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported patient underwent total hip arthroplasty and presented at 7.5 months post operatively with worsening pain in the right hip.Workup revealed periprosthetic joint infection, and loosening of the acetabular component.Patient underwent 2 stage exchange including radical debridement and delayed reimplantation.During the stage 2 revision, patient experienced about 800 ml of blood loss.Patient was also noted to have significant heterotropic bone and a large trochanter fragment requiring placement of a supercable.Devices were implanted with no noted complications.

• Brand Name: G7 SCREW 6.5MM X 30MM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7764254
• MDR Text Key: 116467203
• Report Number: 0001825034-2018-07156
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000999
• Device Lot Number: 3937201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 111