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

Model Number N/A

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical product: tprlc 133 fp type1 pps so 7.0, catalog #: 51-100070, lot #: 6246315.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Original bhp surgery was performed on (b)(6) 2020.It was reported that the head had come off the stem neck.Subsequently, a revision procedure was performed on (b)(6).The stem was used without replacing the original surgical 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.Original bhp surgery was performed on (b)(6) 2020.It was reported that the head had come off the stem neck.The revision surgery was performed on (b)(6)2020.The stem was used without replacing the original surgical product.The returned head was inspected and showed signs of abrasion (rub) marks but no other damage is evident.The most likely root cause is the taper was not cleaned and dried leaving debris in the contact area between the taper and the stem however the true root cause cannot be identified as the returned head is conforming to specification and 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: 11 june 2017 to 07 oct 2020.(b)(4)sold the given period.2 similar complaint identified.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.Corrective and preventive actions: the product item no.650-1158 / batch no.2018090705 has not been involved in any previous field actions.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.

Event Description

Original bhp surgery was performed on (b)(6)2020.It was reported that the head had come off the stem neck.Subsequently, a revision procedure was performed on (b)(6).The stem was used without replacing the original surgical product.

• 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: 10238241
• MDR Text Key: 197733450
• Report Number: 3002806535-2020-00309
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1158
• Device Lot Number: 2018090705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention