MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM -3 NK; HIP ARTHROPLASTY

Model Number	N/A
Medical Device Problem Codes	No Device Output (1435); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: g7 pps ltd acet shell 52e, catalog #: 010000663, lot #: 6578868.Medical product: g7 neutral e1 liner 36mm e, catalog #: 010000857, lot #: 6592218.Medical product: echo por fmrl nc 8x120mm, catalog #: 192008, lot #: 083280.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a study patient had a left total hip arthroplasty on (b)(6) 2020.Subsequently, she complained of severe pain with activity and was diagnosed with left hip iliopsoas/flexor tendonitis, trochanteric bursitis, and abductor tendonitis.No revision has been scheduled.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided.In addition, 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 complaints database over the last 3 years has found 2 similar complaints for this item code 12-115120 for similar event.Trends were identified from complaint history review.2 complaints were reported with same lot number: 2986013.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Risk assessment: the risk file documents the estimated residual risk associated with the reported event.The root cause of the severe pain and associated tendonitis/bursitis cannot be determined with the information provided.Therefore a line for a specific hazard could not be selected for assessment.However, pain or ache is documented as a harm as a potential outcome of a number of hazards.Pain or ache is considered as 3 harms - either minor, moderate or critical.The outcome of this complaint does not report any intervention, and so is in line with the lower severity of pain, or ache minor which is considered a severity of 2 (illness or injury that does not require prescribed medical or surgical intervention).If further information is provided regarding the root cause of the event then risk should be reassessed.
Event or Problem Description
It was reported that a study patient had a left total hip arthroplasty on (b)(6) 2020.Subsequently, she complained of severe pain with activity and was diagnosed with left hip iliopsoas / flexor tendonitis, trochanteric bursitis, and abductor tendonitis.No revision has been scheduled.
Additional Manufacturer Narrative
(b)(4).This final/follow-up report is being submitted to relay additional information.Additional information received: e1: location of surgery was (b)(6) hospital.An ae was reported for patient (b)(6).Six month follow-up 05 august 2020.One year follow-up03 february 2021 ¿ reporting pain(page no: 52) six month follow-up 05 august 2020 (updated crf pg.1-68).Eq-5d-5l¿moderate problems with self-care.Extreme pain or discomfort.Severe problems ambulating.(pg.28) health score ¿ 50.One year follow-up 03 february 2021.Eq-5d-5l ¿moderate problems with self-care.Extreme pain or discomfort.Severe problems ambulating.(pg.30) health score ¿ 15.Study completion per protocol 03 february 2021.Ae 03 february 2021 (pg.54) persistent lateral hip pain.Possibly related to procedure/device.Medical observation and standard physical therapy (multiple months).Outcome pending.Noted as related to surgical procedure.Noted as not normal or expected postop symptom/observation/complication (pg.60).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 or Problem Description
It was reported that a study patient had a left total hip arthroplasty on (b)(6) 2020.Subsequently, she complained of severe pain with activity and was diagnosed with left hip iliopsoas/flexor tendonitis, trochanteric bursitis, and abductor tendonitis.Further information received indicating that the patient continues to present with pain, difficulty with self-care, and problems with ambulation at the six month and one year follow-ups.Physical therapy pre-scribed.Outcome pending.Patient completed study (b)(6) 2021.

• Brand Name: CER BIOLOXD MOD HD 36MM -3 NK
• Common Device Name: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10086453
• Report Number: 3002806535-2020-00259
• Device Sequence Number: 19449128
• Product Code: LZO
• UDI-Device Identifier: 00887868248474
• UDI-Public: 00887868248474
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K061312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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: 12-115120
• Device Lot Number: 2986013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 08/24/2020; 02/17/2021
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 08/28/2020; 02/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Weight: 70