MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 58G; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Year of birth: (b)(6).Concomitant medical products: 192113 841050 echo por fmrl lat nc 13x145mm; 163669 925900 32mm mod head cocr std neck; 010000851 6509364 g7 neutral e1 liner 32mm g.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00374, 0001825034 - 2021 - 00375, 0001825034 - 2021 - 00377.

Event Description

It was reported that a clinical study patient underwent primary total hip arthroplasty.Subsequently, the patient experienced external rotator muscle rupture and underwent re-suture repair approximately one year post implantation.No implants were removed or exchanged, and remains implanted.Additional information on the reported event is unavailable.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

It was reported that there was a primary left tha performed.At a follow up doctor visit, it is noted that the patient was recovering normally but when visiting with a physiotherapist, the patient more vigorously set out to practice range of motion with a pilates roller, and from this the hip became irritated with posterior pain.The patient had pain and instability noted after this event in which an mri was done, which produced results consistent with a ruptured tendon and also signified correct implant positon.The patient did not respond to conservative treatment and underwent a tendon.It was noted the fascia had been caught in the trochanter and external rotators and the patient recovered well from the procedure.The device was not removed or repositioned and remains in place.As a patient recovers from implant surgery an exercise or pt program is routinely prescribed in order for the patient to return to an optimum level of function.During the post- operative period the patient is also recovering from the trauma of surgery at varying rates.Based upon the information provided, the patient was participating in a program and while performing more vigorous activities and appears injured themselves with use of a roller.Upon review of the additional information, the device was not removed, there is no allegation to the device to this event thus ruling out the device and should be non-reportable.

Event Description

It was reported that there was a primary left tha performed.At a follow up doctor visit, it is noted that the patient was recovering normally but when visiting with a physiotherapist, the patient more vigorously set out to practice range of motion with a pilates roller, and from this the hip became irritated with posterior pain.The patient had pain and instability noted after this event in which an mri was done, which produced results consistent with a ruptured tendon and also signified correct implant positon.The patient did not respond to conservative treatment and underwent a tendon.It was noted the fascia had been caught in the trochanter and external rotators and the patient recovered well from the procedure.The device was not removed or repositioned and remains in place.As a patient recovers from implant surgery an exercise or pt program is routinely prescribed in order for the patient to return to an optimum level of function.During the post- operative period the patient is also recovering from the trauma of surgery at varying rates.Based upon the information provided, the patient was participating in a program and while performing more vigorous activities and appears injured themselves with use of a roller.Upon review of the additional information, the device was not removed, there is no allegation to the device to this event thus ruling out the device and should be non-reportable.

• Brand Name: G7 PPS LTD ACET SHELL 58G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11290486
• MDR Text Key: 230689186
• Report Number: 0001825034-2021-00376
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000666
• Device Lot Number: 6519522
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/07/2021
• Supplement Dates Manufacturer Received: 03/05/2021; 03/22/2021; 04/29/2021
• Supplement Dates FDA Received: 03/09/2021; 03/25/2021; 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 83