MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHETIC, HIP

Model Number N/A

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Unstable (1667); Malposition of Device (2616); Unintended Movement (3026); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Subluxation (4525); Metal Related Pathology (4530)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item# 20124006 | item name g7 longevity high wall40mm f | lot# unknown; item# 00625006530 | item name bone screw self-tapping 6.5 mm dia.30 mm length | lot# unknown; item# 00625006525 | item name bone screw self-tapping 6.5 mm dia.25 mm length | lot# unknown; item# 00625006520 | item name bone screw self-tapping 6.5 mm dia.20 mm length | lot# unknown; item# 650-1058 | item name cer bioloxd option hd 40mm 0 | lot# unknown; item# 650-1064 | item name cer option type 1 tpr sleve -6 pe 1 | lot# unknown; item# 51-108080 | item name tprlc 133 mp t1 pps so 8x101mm | lot# unknown.The device will not be returned for analysis since location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.

Event Description

It was reported the patient stated she underwent a tha six(6) months ago, the patient underwent a revision on a unknown date due to the hi-wall liner disengaging and a mal-positioned cup.Patient stated she has experienced squeaking, popping and slipping of the hip and xrays have shown the liner appears loose.Patient stated her hip almost pops out but then pops back in to place, pushing on the pelvis and joint area causing pain, misalignment and hinders the ability to walk.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

D10: item# 20124006 | item name g7 longevity high wall40mm f | lot# 64577165 item# 00625006530 | item name bone screw self-tapping 6.5 mm dia.30 mm length | lot# j6813932 item# 00625006525 | item name bone screw self-tapping 6.5 mm dia.25 mm length | lot# j6817641 item# 00625006520 | item name bone screw self-tapping 6.5 mm dia.20 mm length | lot# 64558809 item# 650-1058 | item name cer bioloxd option hd 40mm 0 | lot# 3032856 item# 650-1064 | item name cer option type 1 tpr sleve -6 pe 1 | lot# 3031442 item# 51-108080 | item name tprlc 133 mp t1 pps so 8x101mm | lot# 6685818  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Medical records were provided and reviewed by a health care professional.A definitive root cause cannot 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

It was reported the patient stated she underwent a tha.Subsequently, patient underwent a revision 3 months later.Surgeon reported that liner had dissociated and there was direct ceramic head contact with shell, leading to metallosis, metallic debris, implant wear to shell, and pseudotumor.No further event information available at the time of this report.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11783966
• MDR Text Key: 249275669
• Report Number: 0001825034-2021-01333
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 010000664
• Device Lot Number: 6803742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• 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 Weight: 79