MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 28/0MM T1; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical products: medical product: e1 ringloc bipolar 28x48 mm, catalog #: 110010457, lot #: 270480.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that following insertion of the head and liner into the cup, the head did not move smoothly.This surgery was finished with backup product.

Event Description

It was reported that following insertion of the head and liner into the cup, the head did not move smoothly.This surgery was finished with backup product.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.It was reported when it was inserted into the cup after putting a head into the liner of e1 bipolar cup, the head did not move more smoothly than usual.This event occurred during surgery.This surgery was finished with backup product.The returned head was inspected and showed signs of handling marks but no other damage is evident.A dimensional inspection was carried out and the item was conforming to specification.The most likely root cause is debris in the contact area between the liner and the head however the true root cause cannot be identified as the returned head is conforming to specification, the complaint cannot be recreated as we do not have the mating parts.A review of the complaints database shows that we have received 2 reported events for movement issues for the same item number 650-1158 prior to the reported event.Risk assessment: a.Severity assessment: the severity associated with the above line is 1 (negligible).This gives a severity score of 1, no impact to patient management.The actual severity score is in line with the risk file.B.Occurrence rate assessment: 22 may 2017 to aug 2020: (b)(4) items sold the given period.2 complaints reported during the time period.Occurrence ratio: (b)(4).Risk score: severity 1 x occurrence 3 = 3 (low risk).The severity of the reported event and calculated occurrence for similar complaints are in line with the risk file the overall score is low risk.No corrective/preventive actions are deemed necessary at this time.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.

• Brand Name: DELTA CER FEM HD 28/0MM T1
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10128060
• MDR Text Key: 194317060
• Report Number: 3002806535-2020-00283
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K131684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1158
• Device Lot Number: 2019080377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1