MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/05/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown head, lot #: unknown; item #: unknown, unknown liner, lot #: unknown; 166025 integral revision 15x225mm lf 317640.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product 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 - 2020 - 03103, 0001825034 - 2020 - 03105, 0001825034 - 2020 - 03106.

Event Description

It was reported that patient underwent left total hip arthroplasty and was revised seventeen years later due to pelvic bone fracture.The patient claims to still be in pain and has difficulty standing and walking.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, b7, g4, h2.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 that the patient experienced traumatic left hip injury at age 14 and had a cup arthroplasty performed.Nine years later, the patient tripped and fell.The fall trauma resulted in a full left hip replacement.The patient was revised seven years post initial full hip replacement due to pain, recurrent dislocations and instability.Patient revised again twenty four years post full that due to pain and pelvic bone fracture.She was told her hip stem was too long and she walked on it wrong for years causing her pelvic to snap.During the revision her surgeon was unable to remove the stem due to it being too deep.He opted to revise her acetabular side to compensate.Patient reports that she is still in pain and has difficulty standing and walking.Attempts have been made and no further information has been provided.

Event Description

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565 - 2020 - 03112.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565 - 2020 - 03112.

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10387108
• MDR Text Key: 202524125
• Report Number: 0001825034-2020-03104
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 08/20/2020
• Supplement Dates FDA Received: 08/21/2020; 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Weight: 82