MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN EXCEED CUP 54 GENERIC; HIP PROSTHESIS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/19/2022

Event Type  Injury  

Event Description

It was reported, that: the patient has undergone revision surgery due to recurring dislocations of freedom constrained liner in an exceed size 54 cup.This has been treated with closed reduction, but it is decided to revise the liner to a different constrained liner solution, to solve the luxation.When opening the patient, the head is in the liner, but when trying to luxate the head out of the cup the liner comes out of the socket of the cup and seems like it was not locked into the cup.Furthermore, the head has many visual scratches when inspected and it seems that there is a deformation of the inner rim of the liner.The old locking ring is taken out and replaced with a new one and the r/c ii constrained liner is inserted in the socket and locked in, checking that the liner is locked.A new 32mm cocr head t1 is attached to the stem and together with the locking ring on the constrained liner attached in the constrained liner.The surgeon wants to have the liner inspected as he doesn¿t find a connection between the dislocations and the findings when the patient is operated on.

Manufacturer Narrative

(b)(4).Concomitant medical products: freedom constr hd 36mm t1 std, item number: 11-107018, lot number: 224690, freedom ringloc -x +5 54/36mm, item number: 11-253654, lot number: 6491327.Foreign source: denmark.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00227, 3002806535-2022-00362.The head, liner, and ringloc shell locking ring were returned for evaluation.The head and liner were still assembled when received.The liner was observed to exhibit score marks and scratches on the scallops and on the outer circumference.The rim of the liner was also observed to have been scratched and deformed in one area.The head has multiple surface scratches throughout one hemisphere with what appears to be metal transfer being evident also.The locking ring was observed to be over-compressed at the split point and exhibited a score mark at the split point.Device is used for treatment.The investigation confirmed that the products used during surgery are compatible and a legally marketed combination of products.This combination would not be expected to contribute to the reported issue.The revision surgery report states that when attempting to luxate the femoral component during surgery, the whole construction came out (stem/head/insert).There is a small wear mark on the liner and the head is scratched in several places.The locking ring is stuck at one side while it¿s mobile (as it should be) at the other side.The stem is fixed well.Radiographs were provided and reviewed by a health care professional.Dislocation was confirmed.No contributing factors were detected.Based on the investigation and provided information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN EXCEED CUP 54 GENERIC
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15275051
• MDR Text Key: 298390665
• Report Number: 3002806535-2022-00362
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 56 KG