MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/10, TAPER 12/14; ZIMMER POROLOCK MIS STEM

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); Swelling/ Edema (4577)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Medical product: liner and shell with plastic barrier 44 mm i.D.54 mm o.D.Do not remove ceramic liner do not reposition cup after final seating; item# 00151505444; lot# 62227925.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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).

Event Description

Patient was implanted on an unknown side and at the seven-year visit the patient was diagnosed with supra acetabular cavity osteolysis.Ct scan and evaluation of inflammation from esr and crp done.Serum titanium levels and a joint aspiration to obtain samples for cultures, cell count and metal ion levels to be performed.

Manufacturer Narrative

Additional information which was received on dec 16, 2020.Additionals: a1, b3, b7, h1.Corrections: b4, b5, g4, g7, h10.The manufacturer received 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 left side and at the seven-year visit the patient was diagnosed with supra acetabular cavity osteolysis.Ct scan and evaluation of inflammation from esr and crp done.Serum titanium levels and a joint aspiration to obtain samples for cultures, cell count and metal ion levels to be performed.

Event Description

Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.1.Event description: it was reported the patient had an initial left tha on (b)(6) 2013.At the seven-year visit, on (b)(6) 2020 the patient was noted to have supraacetabular cavity osteolysis and radiolucency.Harm: s2 - bone resorption and/or osteolysis not leading to revision hazardous situation: fragments of an implant and/or bone are generated in vivo.2.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.Operative information notes from the initial surgery dated (b)(6) 2013: the notes have been reviewed, however no conspicuous findings relevant to the reported event have been identified.There were no intraoperative complications noted.X-rays: several preoperative and postoperative x-rays, as well as postoperative follow-up x-rays with intervals of 3 years, 5 years and 7 years were received.Additionally, ct-scans were received.Along with these x-rays, an email response from dr.(b)(6) (surgeon) has been received, in which he is the sme and states an acetabular inclination angle: 34 degrees, index of acetabular version: 16, periprosthetic radiolucency affecting the femoral and acetabular component in relation to prosthetic mobilization.Osteolysis area of 47x25 mm in acetabular wall.No joint effusion.Timeline provided by the nurse review group (hcp), derived from linked complaint (b)(4): review of the received zper with the following findings: supraacetabular cavity osteolysis confirmed by ct esr and crp ¿ normal joint aspiration and metal ion levels to be conducted review of the following received email (b)(4) external re: adverse event report email with the following findings: acetabular inclination angle: 34 degrees.Index of acetabular version: 16.Periprosthetic radiolucency affecting the femoral and acetabular component in relation to prosthetic mobilization.Osteolysis area of 47x25 mm in acetabular wall.No joint effusion.No evidence of infection or elevated metal ion levels based on provided lab information review of the received (b)(4) mri results (b)(6) 2021 translated.Pdf with the following findings: mri of both hips performed, uncemented bilateral total hip prosthesis periprosthetic osteolysis in left acetabulum, findings compatible with granulomatous reaction/fluid reactive synovitis 3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.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.5.Conclusion: it was reported the patient had an initial left tha on (b)(6) 2013.At the seven-year visit, on (b)(6), 2020 the patient was noted to have supraacetabular cavity osteolysis and radiolucency.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).Medical records were provided and reviewed by a healthcare professional.During the patient's seven year visit, supraacetabular cavity osteolysis was confirmed by ct.However, the patient is completely asymptomatic and satisfied with the result of the surgery.Periprosthetic radiolucency affecting the femoral and acetabular component in relation to prosthetic mobilization was also identified.No potential correlation between the reported event of supraacetabular cavity osteolysis and the biolox head or the fitmore stem could be identified.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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).The following reports are associated with this event: 0001822565-2020-04149- 2 (zimmer biomet, inc.).0009613350-2020-00621-2 (zimmer switzerland manufacturing gmbh).

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/10, TAPER 12/14
• Type of Device: ZIMMER POROLOCK MIS STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11077371
• MDR Text Key: 223779861
• Report Number: 0009613350-2020-00619
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00889024591936
• UDI-Public: 00889024591936
• Combination Product (y/n): N
• PMA/PMN Number: K071723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.310
• Device Lot Number: 2649759
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 10/19/2021
• Supplement Dates FDA Received: 01/07/2021; 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Weight: 95