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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Fall (1848); Hematoma (1884); Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# unknown, unknown stem, lot# unknown.Item# unknown, unknown head, lot# unknown.Item# unknown, unknown liner, lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the products remain 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: 0001825034-2019-04465, 0001825034-2019-04467, 0001825034-2019-04469.

Event Description

It was reported that patient received injection shot for pain one and a half years post initial right hip arthroplasty.Patient reports experiencing pain and muscle spasms in the left leg and hears clicking sounds.Patient also reports severe headaches for past 15 months.Attempts were made to obtain additional information; however, none if available.

Event Description

It was reported that the patient underwent an initial right hip arthroplasty.Subsequently, the patient reports worsened leg length discrepancy after surgery requiring adjustment of his shoe lift to accommodate ambulation.He further reports he is still experiencing pain, muscle spasms, and clicking sounds in the left leg.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Concomitant medical products: 010000859- g7 neutral e1 liner- 3959715, 51-104160- tprlc 133 t1 pps- 3844837, 11-363665- cocr mod hd- 965310.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

Patient underwent an initial right hip arthroplasty.The patient reports worsened leg length discrepancy after surgery requiring adjustment of his shoe lift to accommodate ambulation, welling, and hematoma 1 week post implantation.He received an injection shot for pain 2 years post-op.He is still experiencing pain and has muscle spasms in the left leg.He hears clicking sounds.He has lower back pain.He has suffered from scoliosis since he was 20.He has also had severe headaches for about 15 months.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b7; g4; h2; h3; h6.Reported event was confirmed by review of medical records from patients office visits noting right hip pain, edema, wound discharge and hematoma.Patient fell riding bike landing mostly on left side but torqued his right hip.X-rays reviewed by a third party hcp notes slight change in cup position post the reported fall.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Root cause was unable to be determined.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

No additional event information to report at this time.

• 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: 9161091
• MDR Text Key: 168912923
• Report Number: 0001825034-2019-04464
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/27/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000666
• Device Lot Number: 6007260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/09/2019; 11/12/2019; 01/24/2020
• Supplement Dates FDA Received: 10/25/2019; 12/05/2019; 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Weight: 79