MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEADS, BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM

Model Number N/A

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 12/25/2020

Event Type  Injury  

Manufacturer Narrative

Medical product: shell with cluster holes porous 50 mm o.D.Size hh for use with hh liners.Catalog#: 00-8757-050-01; lot#: 61697324.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard offset.Catalog#: 65771100900; lot#: 61609829.The manufacturer did not receive x-rays, or other source documents for review.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00684.Remains implanted.

Event Description

It was reported that the patient had pain r hip and back and pinched nerve.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that the patient underwent initial right hip arthroplasty on (b)(6) 2011 and experienced trochanteric bursitis on (b)(6) 2013, which was treated with heel raises and an injection on (b)(6) 2014.The patient experienced hip pain and a pinched nerve on (b)(6) 2021 and started physical therapy, which is resolved.The implants remain intact.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: one ap x-ray of the pelvis dated (b)(6) 2021 with an annotation stating weight bearing has been received.This image has been reviewed by external radiologists (hcp) with the following assessment: ap film of the [pelvis] demonstrates a right total hip arthroplasty without hardware failure or loosening.No acute fracture seen.Additionally, the fit of the implants has been assessed as being normal and no cause for pain could be identified.Surgical report: the surgical report for the initial implantation dated (b)(6) 2011 has been received: indication: right hip pain and reduced mobility.Advanced oa on xr.Procedure: right total hip replacement using cement.Patient data: (b)(6), 1943, female, 74kg, 155cm.Nurse review group timeline report received, whereby the primary surgical report as well as the received crf report for study coc09_h02 were reviewed with the following findings: (b)(6) 2011 primary surgery (pg 32).Spinal posterior approach, ebl 200 ml no complications d/c; skilled nursing home, routine pt (b)(6) 2011 6 weeks post op (pgs 40-57) leg length discrepancy; left short 1.0 cm satisfied and participates in mild activities mild pain, ambulates with cane with moderate limp, can walk 6 blocks rom: flexion 120, abduction 40, adduction 0, external rotation 40, internal rotation 20 (b)(6) 2012 6 months post op (pgs 58-73).Satisfied and participates in moderate activities mild pain, limping all the time, unlimited walking distance without assistive device leg length discrepancy; left short 0.5 cm rom: flexion 90, abduction 40, adduction 0, external rotation 20, internal rotation 10 (b)(6) 2012 1 yr follow up (pgs 76-89).Leg length discrepancy; left short 1.0 cm no pain, no limp, no assistive device, unlimited walking distance rom: flexion 120, abduction 45, adduction 0, external rotation 45, internal rotation 10 (b)(6) 2013 2 yr follow up (pgs 90-105).Leg length discrepancy; left short 1.0 cm rom: flexion 100, abduction 40, adduction 0, external rotation 40, internal rotation 20 ae: 3 month history of pain on abduction right hip pain right thigh increased lateral side (trochanteric bursitis), treatment heel raise (pg 170).(b)(6) 2014 3 yr follow up (pgs 106-123).Leg length equal.Rom: flexion 120, abduction 45, adduction 0, external rotation 45, internal rotation 20 ae: injection right hip for trochanteric bursitis (pg 172) (b)(6) 2016 5 yr follow up (pgs 124-141) leg length discrepancy; left short 0.5 cm rom: flexion 90, abduction 40, adduction 0, external rotation 40, internal rotation 20 (b)(6) 2018 7 yr follow up (pgs 142-157) moderate pain leg length discrepancy; left short 1.0 cm rom: flexion 120, abduction 40, adduction 0, external rotation 40, internal rotation 20 (b)(6) 2021 10 yr follow up (pgs 158-167) rom: flexion 120, abduction 45, adduction 0, external rotation 40, internal rotation 20 ae: pain right hip and back, questioning pinched nerve, treatment physiotherapy, resolved (musculoskeletal non-hip) (pg 178) product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: ncr(s): the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found: biolox delta ceramic liner: 1 part was scrapped due to stains on the surface area biolox delta ceramic femoral head: 1 part was scrapped due to it falling to the ground.Conclusion: it was reported that the patient underwent initial right hip arthroplasty on (b)(6) 2011 and experienced trochanteric bursitis on (b)(6) 2013, which was treated with heel raises and an injection on (b)(6) 2014.The patient experienced hip pain and a pinched nerve on o(b)(6) 2021 and started physical therapy, which is resolved.The implants remain intact.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).No x-rays throughout the course of treatment apart from one x-ray taken on oct 12, 2021 were received.With no complete x-ray follow up it is not possible to evaluate possible changes to the bone and / or implant position in order to investigate possible contributing factors.However, the single received x-ray was reviewed by external hcp with no abnormalities or potential triggers for pain being identified.Additionally, the patient underwent physiotherapy treatment with the reported issue noted as being resolved.Based on the received crf report the reported event can be confirmed.However, pain cannot be related to a single specific failure mode.Based on the given information, a root cause analysis is therefore not possible.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient underwent initial right hip arthroplasty and experienced trochanteric bursitis which was treated with heel raises and an injection.The patient experienced hip pain and a pinched nerve and started physical therapy, which is resolved.The implants remain intact.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEADS, BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13107565
• MDR Text Key: 282890745
• Report Number: 0009613350-2021-00685
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: 00889024430327
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-02
• Device Lot Number: 2596620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2011
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 74 KG