MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM STD NK; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event was previously reported by medwatch facility (b)(4) during the investigation it was noticed that zimmer biomet winterthur is not the legal manufacturer of the device.Zimmer biomet bridgend is responsible for the item # 12115121 cer biolox mod hd 36mm.Associated product : item number 00875101236 item name neutral liner 36 mm i.D.Size kk for use with 56 mm o.D.Size kk shell lot # 6335787.This product was reported by medwatch facility (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient reported bending over to use a dust pan and felt 3 pops and grinding.The patient was revised.Once the incision was made, it was noticed that the biolox head was cracked in half.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient reported bending over to use a dust pan and felt 3 pops and grinding.The patient was revised.Once the incision was made, it was noticed that the biolox head was cracked in half.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g5, g7, h1, h2, h3, h4, h6, h10.D11: medical product: neutral liner 36 mm i.D.Size kk for use with 56 mm o.D.Size kk shel, catalog #: 00875101236, lot #: 63357587 medical product: 3.2mmx30mm rnglc+ acet drl bit, catalog #: 31-323230, lot #: 307980 medical product: shell with cluster holes porous 56 mm o.D.Size kk for use with kk liners, catalog #: 00875705601, lot #: 63765514 medical product: bone screw self-tapping 6.5 mm dia.20 mm length, catalog #: 00625006520, lot #: 63882515 medical product: bone screw self-tapping 6.5 mm dia.35 mm length, catalog #: 00625006535, lot #: 63729964 medical product: tprlc 133 fp type1 pps ho 14.0 t1, catalog #: 51-101140, lot #: 3982295 as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaint for this item code 12-115121.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to head cracked in half.Risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available.The severity is 4, which is described in the severity table as: s-4 results in permanent impairment of body function or permanent damage to a body structure ¿ revision resulting in permanent impairment.The outcome of the reported event therefore is in line with the rmf.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product has not been returned.

• Brand Name: CER BIOLOXD MOD HD 36MM STD NK
• Common Device Name: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9791741
• Report Number: 3002806535-2020-00117
• Device Sequence Number: 2495223
• Product Code: LZO
• UDI-Device Identifier: 00887868248481
• UDI-Public: 00887868248481
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12-115121
• Device Lot Number: 2911060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 121