MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: wagner cone prosthesisâ®, 135â°, uncemented, 㸠17, taper 12/14; catalog no#: 01.00561.317; lot#: 3017160.G7 osseoti 3 hole shell 50mm d 0mm d; catalog no#: 110010243; lot#: 6833659.Liner neutral 36 mm i.D.Size d for use with g7 acetabular system only; catalog no#: 30103604; lot#: 64843270.Concomitant medical products - therapy date: (b)(6) 2021.The manufacturer did receive clinical study data and warsaw timeline report for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.(b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to infection and pain.

Manufacturer Narrative

D10: medical product: wagner cone prosthesis, 135, uncemented, 17, taper 12/14; catalog#: 01.00561.317; lot#: 3017160 g7 osseoti 3 hole shell 50mm d 0mm d; catalog#: 110010243; lot#: 6833659, liner neutral 36 mm i.D.Size d for use with g7 acetabular system only catalog#: 30103604; lot#: 64843270.Therapy date: (b)(6) 2021.Additional information was received on feb 24, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to infection and pain.

Manufacturer Narrative

Additional information which was received on feb 04, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received x-rays and other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to infection and pain.

Event Description

No change to previously reported event.

Manufacturer Narrative

Event description: it was reported that a study patient underwent an initial right tha on (b)(6) 2020.Subsequently, the patient experienced surgical site wound dehiscence, drainage and was diagnosed with deep infection.The patient had phase 1 device removal, i&d, resection, and antibiotic spacer placement on (b)(6) 2021.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.Medical records: following a summary of the received medical records consisting of the clinical report form and progress notes: preoperative contributing factors: osteoarthritis, pain 7/10, difficulty ambulating, right leg short by 2mm.Intra and postop findings: initial right tha with no noted intra or postoperative complications.Progression note from (b)(6) 2020: superficial infection, wound dehiscence, wound drainage, patient reports rash that appeared on chest and surgical site, medical intervention.Progression note from (b)(6) 2020: erythema has improved.Drainage increased over the weekend requiring 2-3 dressing changes daily but this has improved as well.Pain is located along incision and lateral thigh but denies hip joint/ groin pain.She has continued bactrim ds bid.Distal incision erythematous with fibrinous exudate, clear drainage.Erythema and swelling improved.No hip joint pain with active or passive motion of hip but notes discomfort along incision.Progression note from (b)(6) 2020 ¿ right hip pain, aspiration of right hip joint.Progression note from (b)(6) 2021: patient returns for 8-week follow up after right hip replacement with distal wound dehiscence.The patient's pain is 7/10 when standing with oral medications.Pain is located mid quad and adductor.Denies groin pain.She has continued bactrim ds daily.Distal incision almost completely closed with minimal blood, no active drainage.Erythema and swelling improved.No hip joint pain with active or passive motion of hip.Ttp along quadriceps.Pain with resisted knee extension.The patient can flex to 100 degrees at the hip, abduct 20 degrees actively, and ambulates with antalgic gait.Progression note from (b)(6) 2021 ¿ full weight bearing antalgic gait, taking pain medication for operative joint, unable to perform exercises, removed from study 21 (b)(6) 2021.Adverse event (b)(6) 2021 ¿ deep infection, complication of skin involving drainage from surgical wound, right hip i&d, resection and placement of antibiotic spacer on (b)(6) 2021 the primary surgical report from 09 nov 2020 was review with no anomalies noted.Product evaluation: the products were discarded; therefore, a product evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Sterilization certificate: the gamma sterilization specification of the devices certifies the suitability of sterilization.The irradiation certificates of the affected lot numbers have been reviewed and were found to be according to specifications.Conclusion: it was reported that a study patient underwent an initial right tha on (b)(6) 2020.Subsequently, the patient experienced surgical site wound dehiscence, drainage and was diagnosed with deep infection.The patient had phase 1 device removal, i&d, resection, and antibiotic spacer placement on (b)(6) 2021.Based on the medical records provided, the wound dehiscence and the suspected infection can be confirmed.Nevertheless, the reported infection could not be confirmed with certainty due to the lack of laboratory results.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).Sterilization certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issue that may have affected the implant safety or effectiveness, the implanted products are not identified as the source or contributing factor to the reported infection.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).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11278408
• MDR Text Key: 230239592
• Report Number: 0009613350-2021-00055
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: 00889024430358
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-01
• Device Lot Number: 3031183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/04/2021; 02/24/2021; 07/23/2021
• Supplement Dates FDA Received: 02/17/2021; 03/08/2021; 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 45